Year in Review: Orthopedic Companies with First U.S. Products
by Julie A. Vetalice | Jan 2020
One of our favorite lists that we compile every year is newer companies that hit our radar. This review pinpoints 17 companies that received their first FDA 510(k) clearances last year, so you’ll mostly find new names in the segments of Joint Replacement, Spine, Trauma Sports Medicine. ... Read more »
FDA 510(k) Recap: 9 First Clearances and Line Extensions
by Julie A. Vetalice | Jan 2020
This month’s recap highlights devices of interest that received first clearances from companies new on our radar, like Augmedics, Avanti Orthopaedics, NanoOrtho, Nebula Surgical and Sonex Health, and the latest devices from Integra, Think Surgical, ExsoMed and Pantheon Spinal. ... Read more »
Silver Bullet Therapeutics Gains CE Mark for OrthoFuzIon Bone Screw
by Julie A. Vetalice | Jan 2020
An expanded CE Mark positions the company to improve patient care in the EU, and potentially disrupt the established commercial trauma market. ... Read more »
RTI Surgical to Become Pure-Play Spine Company with Sale of OEM Business
by Julie A. Vetalice | Jan 2020
Subsequent to closing of the $490 million transaction, the company will be a global spine company targeting double-digit growth. ... Read more »
ASTM Launches Personnel Certificate in Additive Manufacturing
by Julie A. Vetalice | Jan 2020
Specific modules will address terminology, AM process overview, design and simulation, post-processing, mechanical testing, etc. ... Read more »
Exactech Names New CEO, Darin Johnson
by Julie A. Vetalice | Jan 2020
New President and CEO Darin Johnson will build on Exactech’s foundation in joint replacement following two strong years of sales and investments in R&D, people and infrastructure. ... Read more »
Johnson & Johnson Bolsters Digital Surgery Tools with Verb Surgical
by Julie A. Vetalice | Jan 2020
JNJ, parent to DePuy Synthes Companies, entered into an agreement to acquire the remaining ownership stake in Verb Surgical. The transaction is expected to close in 1H20. ... Read more »
Augmedics Launches xvision AR Surgical Guidance
by Julie A. Vetalice | Jan 2020
The augmented reality system allows surgeons to visualize anatomy in real time, as if using x-ray vision, to guide instruments and implants. The first application addresses spinal procedures. ... Read more »
Conventus Orthopaedics Acquires Intramedullary Technology from IntraFuse
by Julie A. Vetalice | Jan 2020
Conventus Orthopaedics is expanding into lower extremity applications, adding to its self-expanding nitinol Conventus CAGE technology for novel 3-dimensional fracture management in the distal radius and proximal humerus. ... Read more »
DePuy Synthes, Zebra Medical to Partner on AI in Orthopedics
by Julie A. Vetalice | Jan 2020
Zebra Medical's algorithm-based artificial intelligence technology will be part of DePuy Synthes’ VELYS Digital Surgery solutions for pre-operative, operative and post-operative care of patients undergoing joint, trauma and spine procedures. ... Read more »
Smith+Nephew Announces First JOURNEY II Unicompartmental Knee Procedures
by Julie A. Vetalice | Dec 2019
The JOURNEY II Uni Knee is designed to bring the natural feel of JOURNEY II to partial knee arthroplasty patients and help drive value in healthcare systems. ... Read more »
Empirical Spine Completes Portion of Enrollment for LimiFlex Clinical Trial
by Julie A. Vetalice | Dec 2019
Enrollment is complete in the investigational arm of the U.S. IDE trial of the LimiFlex Paraspinous Tension Band with decompression. ... Read more »
ulrich medical USA Launches Momentum Posterior Spinal Fixation
by Julie A. Vetalice | Dec 2019
Momentum is compatible with the company's neon3 Universal OCT Spinal Stabilization System, which launched in 2012. ... Read more »
Strategic Initiatives: CrossRoads Extremity Builds Portfolio, Mathys and BREHM to Co-Market Products
by Julie A. Vetalice | Dec 2019
A growing extremities company grows even more, and two well-established joint replacement players collaborate globally on components for hip replacement. ... Read more »
4 New Technologies in Spine, Joint Replacement, Trauma, Sports Medicine
by Julie A. Vetalice | Dec 2019
Small and mid-sized orthopedic companies bolstered their portfolios at year-end with products to help grow revenue in the coming year. ... Read more »
CMS to Remove Total Hip Replacement, Certain Spine Procedures from Inpatient Only List
by Julie A. Vetalice | Dec 2019
Removal of these procedures from the inpatient-only list makes them eligible to be paid by Medicare in hospital outpatient and inpatient settings. ... Read more »
FDA 510(k) Review: 2019 Additively-Manufactured Product Clearances
by Julie A. Vetalice | Dec 2019
Spine implants accounted for the majority of the additive manufactured products that received FDA 510(k) clearance in 2019. Our review of clearances include the industry's top players and two companies with their very first orthopedic-related 510(k)s: Additive Implants and Addivation Medical. ... Read more »
FDA 510(k) Recap: 10 Products in Joint Replacement and Spine
by Julie A. Vetalice | Nov 2019
This month, we look at companies that received their first orthopedic-related clearance such as FX Shoulder USA, Amplify Surgical and restor3d, and others like Exactech, Smith+Nephew and THINK Surgical that have interesting new technologies or line expansions. ... Read more »
CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion
by Julie A. Vetalice | Nov 2019
Companies affected by this change include RTI Surgical, marketer of the SImmetry® system, and SI-BONE, manufacturer of the iFuse Implant System®. ... Read more »
DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial
by Julie A. Vetalice | Nov 2019
The first of its kind biomaterial is offered as an alternative to PEEK and titanium materials for interbody devices. ... Read more »
Smith+Nephew Launches OR30 Dual Mobility Hip
by Julie A. Vetalice | Nov 2019
OXINIUM Technology is the first advanced bearing material available to support modular dual mobility throughout the entire offering. ... Read more »
FDA Applies Special Controls to Instrumentation for Certain Osteochondral Implants
by Julie A. Vetalice | Nov 2019
FDA has ruled to classify orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls). ... Read more »
THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application
by Julie A. Vetalice | Oct 2019
Previously available in Asia Pacific and European markets, the TSolution One system is now cleared for use in the U.S. in total knee replacement. ... Read more »
3 Stem Cell Product Updates: Knee OA Clinical Trials, Degenerative Disc Treatment Launch
by Julie A. Vetalice | Oct 2019
Clinical trials are underway in the U.S. and China for use of stem cell therapies in the treatment of knee osteoarthritis. U.S. product commercialization is commencing for a regenerative stem cell procedure to treat chronic lower back pain. ... Read more »
Zimmer Biomet, CarboFix and Aegis Spine Make Post-NASS Announcements
by Julie A. Vetalice | Oct 2019
Zimmer Biomet introduced its first porous titanium implants to be additively manufactured. Aegis added expandable cages to its portfolio, and CarboFix launched another device made from carbon fiber. ... Read more »
ADAM to Launch Human Trials of 3D-Printed Bone
by Julie A. Vetalice | Oct 2019
The startup plans to complete pre-clinical trials within the month and commence first human trials by the end of 2019. The project seeks to reduce the cost for synthetic bone production by half. ... Read more »
Smith+Nephew CEO Stepping Down
by Julie A. Vetalice | Oct 2019
Smith+Nephew CEO Namal Nawana will step down from his position on October 31, by mutual agreement, to pursue opportunities outside of the U.K. Incoming CEO, Roland Diggelmann, takes on the role in November. ... Read more »
Stryker, SeaSpine and Innovasis Ink New Licensing Deals
by Julie A. Vetalice | Oct 2019
Conformis will supply patient specific instrumentation to Stryker, Innovasis signed a deal to access porous HA PEEK and SeaSpine is entering the 3D-printed interbody space. ... Read more »
Brainlab, Epica, Onkos Surgical Launch New Surgical Enabling Tools
by Julie A. Vetalice | Oct 2019
Brainlab is back with more robotic technology, Epica’s mobile CT imaging is cleared for human use applications and Onkos enhances joint sparing tumor procedures. ... Read more »
FDA 510(k) Recap: 10 Shoulder Implants and Technologies
by Julie A. Vetalice | Oct 2019
Nine shoulder replacement implants, including two stemless offerings, and one positioning guide received FDA 510(k) clearance thus far in 2019. We recap each product's specifications. ... Read more »
Sports Medicine Product Updates: CoNextions Medical and Fuse Medical
by Julie A. Vetalice | Sep 2019
In keeping an eye on lesser-known companies, we noticed two up-and-comers to share. These small startups are increasingly appearing in the news. ... Read more »
Knee Replacement Launches: ATTUNE Cementless, Persona Revision and Sterizo Total Knee
by Julie A. Vetalice | Sep 2019
Knee segment leaders DePuy Synthes (#3) and Zimmer Biomet (#1) enhanced their offerings and noted that their new knee systems combined with their robotic-assisted systems will boost revenue. Smaller player Fuse Medical launched its next-generation total knee platform and announced further product la ... Read more »
Trauma: A Regulatory and Product Launch Recap
by Julie A. Vetalice | Sep 2019
The number of companies in the trauma space may surprise you since the largest orthopedic players—DePuy Synthes, Stryker, Zimmer Biomet and Smith & Nephew—seem to dominate the news. In anticipation of the OTA Annual Meeting this week, and in response to your requests for continued coverage o ... Read more »
Active Implants Gains FDA Breakthrough Device Designation for NUsurface Meniscus
by Julie A. Vetalice | Sep 2019
Breakthrough Device Designation is designed to ensure that patients and providers have timely access to vital devices. If cleared by FDA, NUsurface would be the first artificial meniscus in the U.S. market. ... Read more »
Stryker Enters Definitive Agreement to Acquire Mobius Imaging and Cardan Robotics
by Julie A. Vetalice | Sep 2019
To bolster its spine division, Stryker is acquiring Mobius Imaging and its sister company, Cardan Robotics for up to $500MM in cash. The acquisition provides Stryker with immediate entry into the intra-operative imaging segment to complement its implant and navigation offerings. ... Read more »
DePuy Synthes Acquiring JointPoint Navigation Assets
by Julie A. Vetalice | Sep 2019
DePuy Synthes and JointPoint have held an exclusive agreement to market JointPoint in the U.S. since 2017. The platform will become a DePuy Synthes-owned component of the ANTERIOR ADVANTAGE system for hip replacement. ... Read more »
Omar Ishrak to Retire as CEO of Medtronic
by Julie A. Vetalice | Sep 2019
Medtronic Chief Executive Officer Omar Ishrak announced his intention to retire in the beginning of 2Q20, following the end of the company’s fiscal year. At that time, he will become Executive Chairman of Medtronic. Geoff Martha will succeed Ishrak as CEO next year. ... Read more »
cultivate(MD) Invests in Genesis Software Solutions for Orthopedics
by Julie A. Vetalice | Sep 2019
The cultivate(MD) Capital Fund II of Genesis Innovation Group made an investment in Genesis Software Innovations (GSI), developer of software solutions that will initially focus on the orthopedic space. ... Read more »
Loci Orthopaedics Gains Funding for Thumb Base Joint Implant
by Julie A. Vetalice | Aug 2019
The company was awarded a €2.5 million grant, received a U.S. patent and entered into a new technology license agreement. ... Read more »
Stryker to Acquire Sterilization Specialist TSO3
by Julie A. Vetalice | Aug 2019
The STERIZONE VP4 Sterilizer is reportedly the most cost-effective low-temperature sterilizer on the market today, per instrument sterilized, compared to hydrogen peroxide low-temp systems. ... Read more »
Zimmer Biomet Gains FDA Approval for Tether Scoliosis Treatment
by Julie A. Vetalice | Aug 2019
The Tether represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years. ... Read more »
Globus Medical Enters Hip, Knee Market with StelKast Acquisition
by Julie A. Vetalice | Aug 2019
Globus Medical also announced the launch of a robotic system for joint replacement in late 2020. The company seeks to leverage recent hardware and software investments in robotic technology. ... Read more »
FDA 510(k) Recap: Spinal Devices and Technologies from 1H19
by Julie A. Vetalice | Aug 2019
Heading into the NASS Annual Meeting, we share product clearances for lesser-known companies to keep on your radar: Integrity Implants, MiRus, Omnia, Silony and more. ... Read more »
CMS Proposes Total Knee and Total Hip Outpatient Changes
by Julie A. Vetalice | Aug 2019
The Center for Medicare and Medicaid Services announced its recommendation to cover total knee replacement in ASCs and total hip replacements in outpatient settings. ... Read more »
Medacta Enters U.S. and Australian Sports Medicine Markets
by Julie A. Vetalice | Aug 2019
Medacta is introducing the Mecta®Lock PEEK Suture Anchor and the Mecta®Screw PEEK Interference Screw in Australia and the U.S. following regulatory clearance of these products. ... Read more »
FDA 510(k) Recap: Large Players Notch Sports Medicine and Orthobiologics Clearances
by Julie A. Vetalice | Jul 2019
Arthrex, CONMED, DePuy Synthes and Zimmer Biomet are among the companies that received FDA 510(k) clearances in June. ... Read more »
by Julie A. Vetalice | Jul 2019
FDA's study of new sterilization methods is in response to ethylene oxide sterilization facility closures. The closures were promoted by air quality issues and created a shortage of sterilization options for some medical device companies. ... Read more »
NuVasive Launches Pulse Integrated Technology Platform for Spine Procedures
by Julie A. Vetalice | Jul 2019
Early clinical experience has demonstrated the Pulse system's utility to improve workflow, reduce surgical variability and increase reproducibility of surgical outcomes. ... Read more »
DJO Launches AltiVate Reverse Short Stem Shoulder in the U.S.
by Julie A. Vetalice | Jul 2019
The bone-sparing short-stem with a 135° neck-shaft angle sits entirely within the humerus, supporting ease of conversion from anatomic to reverse shoulder arthroplasty. ... Read more »
Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody
by Julie A. Vetalice | Jul 2019
The next-generation system was designed to improve simplicity and ease of use for minimally invasive lumbar procedures, and is part of a lumbar fusion solution suite that also includes Orbit discectomy instruments. ... Read more »
Celling Spine Acquires Assets of Link Spine
by Julie A. Vetalice | Jul 2019
Link had sought a company to further develop its system for facet fixation and minimally invasive surgery. Celling believes that this technology complements its current portfolio and supports the development of a biologically enhanced spinal fusion system. ... Read more »
Fusion Robotics Gains Funding to Support Spinal Robotics System
by Julie A. Vetalice | Jul 2019
Fusion Robotics closed a financing round with lead investment by Alex Lukianov of Lukpartners, LLC and Kevin Foley, M.D. Proceeds will help ready the company's spinal robotics platform to obtain regulatory clearance and begin commercialization. ... Read more »
MicroPort Orthopedics Launches Evolution NitrX Medial-Pivot Knee
by Julie A. Vetalice | Jul 2019
The implant features a titanium niobium nitride coating that has been shown in simulated clinical testing to reduce the release of certain metal ions. ... Read more »
Smith & Nephew Acquiring Optical Tracking Technology for CAS
by Julie A. Vetalice | Jun 2019
Atracsys’ fusionTrack 500 optical tracking camera will be a core enabling technology within Smith & Nephew's multi-asset digital surgery and robotic ecosystem. ... Read more »
DT MedTech Granted PMA for Hintermann H3 Total Ankle
by Julie A. Vetalice | Jun 2019
The H3 was developed by Prof. Dr. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The H3 has been implanted in more than 20,000 patients outside of the U.S. since its first release in May 2000. ... Read more »
OrthoPediatrics Acquires Vilex, ExFix Technology
by Julie A. Vetalice | Jun 2019
The company gains access to the Orthex Hexapod, which offers easily calibrated struts and hydroxyapatite coated pins designed to reduce infection risk. It is accompanied by point and click software to simplify deformity correction planning. ... Read more »
FDA 510(k) Recap: Knees, Hips, Shoulders, Wrists and Elbow Joints
by Julie A. Vetalice | Jun 2019
This month we focus on products that rebuild knees, hips and extremities. Two are from companies receiving their first orthopedic-related clearance; most are from folks that you know: LimaCorporate, MicroPort Orthopedics, Zimmer Biomet, and so forth. ... Read more »
Hip Replacement Companies Expand Portfolios with New Product Launches
by Julie A. Vetalice | Jun 2019
A conversation with a surgeon pioneer of the anterior approach and a recap of 10 product launches provide a review of the hip replacement space. ... Read more »
Exactech Acquires EPIC Extremity, Trauma Device Company
by Julie A. Vetalice | May 2019
EPIC Extremity, an early-stage orthopedic device company, was founded to introduce a line of lowest total cost implants to the orthopedic extremity market. ... Read more »
AMDT Gains FDA Clearance for SixFix Hexapod Device
by Julie A. Vetalice | May 2019
The external fixator device is designed to shorten surgical time, simplify inventory and enhance patient care, and is used with SixFix deformity analysis and correction software. ... Read more »
THINK Surgical Completes Enrollment for Study of Active Robot for TKR
by Julie A. Vetalice | May 2019
The company has filed a submission to FDA for clearance to market its active robot for use in total knee replacement procedures. ... Read more »
Xenco Medical Launches Interactive Vending Machines for Spinal Devices
by Julie A. Vetalice | May 2019
Implant maker Xenco Medical has announced the launch of the first interactive vending machines designed for spine surgery instruments and implants. ... Read more »
HealthpointCapital Acquires Majority Stake in CrossRoads Extremity Systems
by Julie A. Vetalice | May 2019
The investment supports growth of CrossRoads' Active Stabilization portfolio of lower-extremity implant systems for orthopedic and podiatric surgeons. ... Read more »
CoreLink Launches Lateral Access and Interbody Fusion Platform
by Julie A. Vetalice | May 2019
CoreLink has introduced a comprehensive platform for lateral MIS spine fusion including 3D printed titanium and PEEK-based implants, retractor and surgical instruments. ... Read more »
ChoiceSpine Granted FDA Clearance for New Cervical Spinal Fusion Devices
by Julie A. Vetalice | May 2019
With these 510(k)s in hand, TIGER SHARK C Cervical Interbody and BOOMERANG Anterior Cervical Plate are set to enter the robust spinal implant market. ... Read more »
FDA 510(k) Recap: Shoulders and Ankles
by Julie A. Vetalice | May 2019
Shoulders and ankles comprise the largest share of the extremities joint reconstruction segment. Arthrex, Catalyst OrthoScience, DJO, Exactech, Stryker and Zimmer Biomet have continued to grow their offerings of these devices in 2019 to keep extremities replacement momentum going. ... Read more »
Maxx Orthopedics' First Successful Procedure with Libertas Hip Replacement
by Julie A. Vetalice | May 2019
The Libertas total hip replacement system comprises cemented and cementless femoral stems, cementless acetabular cups designed for use with highly crosslinked polyethylene modular liners and either Biolox delta or cobalt chrome head options in multiple head diameters and offset options. ... Read more »
In2Bones Launches TriWay TTC Nail Arthrodesis System and Soft Tissue Release System
by Julie A. Vetalice | May 2019
The new TriWay TibioTaloCalcaneal (TTC) Nail Arthrodesis System from In2Bones represents an alternative to traditional cannulated systems used by foot and ankle surgeons to enhance performance, stability and reliability during hindfoot and ankle fusions. ... Read more »
Artoss Gains FDA Clearance of NanoBone SBX Putty for Standalone Use in Fusion
by Julie A. Vetalice | May 2019
NanoBone Bone Graft used as a standalone in posterolateral spinal fusion may represent a significant advancement in patient care. Eliminating the need to mix synthetic graft with autograft or to harvest and concentrate bone marrow aspirate can offer savings of time and money, and can ... Read more »
Konica Minolta Healthcare Gains FDA Clearance for Dynamic Digital Radiography
by Julie A. Vetalice | May 2019
Today, orthopedists rely on external motion and static x-ray to assess joint stability and spinal movement. With DDR, orthopedists and musculoskeletal specialists can acquire a full view of the skeletal system in supine and prone positions to view changes in the bone and articulations throughout the ... Read more »
FDA 510(k) Recap: Adjacent Markets, Additive, Surgical Platforms
by Julie A. Vetalice | Apr 2019
Orthopedic companies large, mid-sized and small are gaining FDA clearance for products in new materials, and made with attractive manufacturing methods like 3D printing. Companies like Kuros Biomedical and Nvision are making strategic decisions to move into adjacent markets. ... Read more »
Orthofix M6-C Artificial Cervical Disc Study: Full 2-Year Data
by Julie A. Vetalice | Apr 2019
The M6-C is a next-generation artificial cervical disc developed to replace an intervertebral disc damaged by degeneration. Its physiologic one-piece design features an artificial nucleus and annulus that mimic the biomechanical motion of a natural disc, to include axial compression or shock ab ... Read more »
Zimmer Biomet Gains FDA Clearance of ROSA ONE Spine System
by Julie A. Vetalice | Apr 2019
The company now has FDA 510(k) clearance for knee, spine and brain applications on one robotic platform. ROSA SPINE features dynamic tracking that allows it to move with the patient, supporting accuracy without the need to be attached to the patient or the surgical table. ... Read more »
Acumed Acquires Elbow Arthroplasty Technology
by Julie A. Vetalice | Apr 2019
The move complements the company's robust portfolio of upper extremity plates and joint replacement devices. ... Read more »
Burst of Orthopedic M&A at the Close of 1Q19
by Julie A. Vetalice | Mar 2019
Companies are taking strides to connect their devices with technologies that support improved patient outcomes. That connection can come in the form of M&A activity—which certainly applies to transactions announced over the month of March in joint replacement. In other segments, companies ... Read more »
AAOS Recap: Regulatory Announcements from the Hall
by Julie A. Vetalice | Mar 2019
This month’s recap highlights regulatory announcements made from the AAOS exhibit hall floor. A few products gained clearance earlier this year and the company strategically held its announcement for this month. ... Read more »
Brainlab Acquires Medineering, Robotics Platform
by Julie A. Vetalice | Mar 2019
Brainlab is creating the first openly scalable medical robotics platform paired with an efficient software ecosystem. ... Read more »
Atreon Orthopedics Receives FDA Clearance for Rotator Cuff Regeneration Device
by Julie A. Vetalice | Mar 2019
The Rotium Bioresorbable Wick supports the regeneration of healthy tendon in the healing of rotator cuff injuries. ... Read more »
Stryker Acquires OrthoSpace, Rotator Cuff Repair Device
by Julie A. Vetalice | Mar 2019
The InSpace device for treatment of massive irreparable rotator cuff tears is a biodegradable sub-acromial spacer, which is designed to realign the natural biomechanics of the shoulder. ... Read more »
Exactech Gains FDA Clearance for Alteon Cup and XLE Liner
by Julie A. Vetalice | Mar 2019
The Alteon Cup is used with the Alteon XLE highly crosslinked vitamin-E enhanced acetabular liners. A patented gamma irradiation and mechanical annealing process, tailored to the vitamin E content, is used to achieve the desired crosslink density for these liners. ... Read more »
Smith & Nephew Acquires Brainlab Joint Replacement Business
by Julie A. Vetalice | Mar 2019
Brainlab provides pre-operative planning, intra-operative navigation and tools for post-op evaluation and information sharing. Smith & Nephew also gains access to cloud computing, tracking, augmented reality, robotics, artificial intelligence, machine learning, image fusion and anatomic segmenta ... Read more »
Smith & Nephew to Acquire Osiris
by Julie A. Vetalice | Mar 2019
The transaction includes BIO4 viable bone matrix, an alternative to autograft, and Cartiform cryopreserved viable osteochondral allograft for articular cartilage repair. ... Read more »
by Julie A. Vetalice | Mar 2019
The company's ligament balancing technology provides a framework for integration into ExactechGPS computer-assisted navigation to further advance the Truliant Total Knee. ... Read more »
Smart Medical Devices Launching SMARTdrill 6.0
by Julie A. Vetalice | Mar 2019
The device is intended to curtail drill and screw plunge, and to accurately measures depth, torque and energy in real-time. ... Read more »
Atlas Spine Launches HiJak AC Expandable Interbody
by Julie A. Vetalice | Mar 2019
HiJak addresses complex cervical conditions, and can adjust both height and lordosis to restore balanced sagittal alignment. ... Read more »
Amplify Surgical's dualX Dual Expanding Interbody Fusion Used in First Cases
by Julie A. Vetalice | Mar 2019
The dualX device expands in both width and height providing a stable foundation for spinal fusion. ... Read more »
CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew
by Julie A. Vetalice | Mar 2019
CurvaFix is developing implantable products to improve bone repair following serious fracture and injury. This is the company’s first product, and first FDA 510(k) clearance. ... Read more »
Aesculap Biologics Announces NOVOCART 3D Trial Enrollment Milestone
by Julie A. Vetalice | Mar 2019
Approximately 117 study participants have been treated, bringing enrollment to 50% completion. ... Read more »
Device Companies Emphasize Coatings in FDA 510(k) Announcements
by Julie A. Vetalice | Mar 2019
Orthopedic joint replacement and spine companies tout their coatings as essential elements to new products. ... Read more »
FDA 510(k) Recap: AQrate, ROSA and First Clearances
by Julie A. Vetalice | Feb 2019
In January, Globus Medical and Zimmer Biomet received key robotic FDA 510(k) clearances, while five companies within the spine, sports medicine and trauma markets received their first clearances. ... Read more »
SIG Medical Gains Additional FDA Clearance for AdvantageRib System
by Julie A. Vetalice | Feb 2019
SIG seeks to provide patient care by reducing complications like pneumonia, time in intensive care units, chronic pain, ventilator support, chest wall deformity, the need for tracheostomy and a significant reduction to the overall cost to the healthcare system. ... Read more »
Royal Philips Launches Zenition Mobile C-Arm
by Julie A. Vetalice | Feb 2019
Zenition addresses hospital challenges as image-guided MIS procedures increase. Philips' MetalSmart software automatically adjusts the contrast and brightness of images to improve image quality when metal objects such as implants are present, which is especially useful in orthopedic applications. ... Read more »
Insight Medical Completes Cadaver Lab with ARVIS Augmented Reality Visualization
by Julie A. Vetalice | Feb 2019
The company plans a 2019 launch of AR navigation for spinal fusion, joint reconstruction and the repair of anterior cruciate ligaments. ... Read more »
AAOS Preview: First-Time Exhibitors, New Offerings on the Exhibit Floor
by Julie A. Vetalice | Feb 2019
Each year, of the hundreds of exhibitors slated to be at the annual American Academy of Orthopaedic Surgeons meeting, I select a few you may not know. After you've gone to look at the robots, here are some other companies to meet. ... Read more »
Aesculap Implant Systems PlasmaporeXP Surface Enhancement Study
by Julie A. Vetalice | Feb 2019
This data reinforces years of clinical experience with the Plasmapore technology, beginning with the surface-enhanced BiContact hip implant over 30 years ago. ... Read more »
Trice Medical Acquires SegWAY Orthopaedics
by Julie A. Vetalice | Feb 2019
The transaction creates the first company to offer product lines for minimally invasive orthopedic diagnostics and surgical solutions. ... Read more »
Orthofix M6-C Disc Granted FDA Premarket Approval
by Julie A. Vetalice | Feb 2019
Clinical data on the disc demonstrated meaningful improvement in pain and lowered disability vs. anterior cervical discectomy and fusion in the treatment of cervical radiculopathy, with or without cord compression. ... Read more »
Osso VR Gains Funding in Support of Virtual Reality Surgical Training
by Julie A. Vetalice | Feb 2019
The virtual reality-based platform is using Small Business Innovation Research Program support to add automation to its surgical assessment tool. ... Read more »
FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019
by Julie A. Vetalice | Jan 2019
Products highlighted here — representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments — include a total hip, cervical plate, interbody fusion system, lumbar fusion system, spacer, pedicle screw systems and more. ... Read more »
Year in Review: Orthopaedic Companies New on Our Radar in 2018
by Julie A. Vetalice | Dec 2018
The companies highlighted here (either brand new or new to us) represent all five major market segments and comprise a broad geographical mix: Denmark, Finland, Israel, Italy, The Netherlands and the United States. ... Read more »
FDA 510(k) Highlights from 2018: Shoulder and Ankle Joint Replacement Products on Tap
by Julie A. Vetalice | Nov 2018
Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs, allowing companies to offer a wider array of products. ... Read more »
Smart Devices, Robotics, Sensors: Tools to Improve Patient Outcomes
by Julie A. Vetalice | Oct 2018
Dr. Martin Roche explains how these technologies are shaping the future of orthopaedic surgery: "A surgeon needs data to make objective decisions intra-operatively. The subjective Art of Surgery is poorly translatable ... Through all this rapid evolution, the clinician must take a leadership role." ... Read more »
NuVasive Announces Christopher Barry to Succeed Gregory Lucier as CEO
by Julie A. Vetalice | Oct 2018
Christopher Barry joins NuVasive from Medtronic, where he has served as Senior Vice President and President, Surgical Innovations, since January 2015. Gregory Lucier will remain Chairman of the Board. ... Read more »
Corin Increases Footprint with Acquisition of Global Orthopaedic Technology
by Julie A. Vetalice | Oct 2018
Global Orthopaedic Technology (GOT), which bills itself as the largest Australian-owned orthopaedic implant designer and manufacturer, was established in 1999 and serves Australia and the U.S.—two markets in which Corin has an established presence. ... Read more »
Big Data, Biologics and Failure Rates Among Significant Interests for Surgeon
by Julie A. Vetalice | Oct 2018
"There has never been a greater need for the lowest rates of failure possible," says Dr. Adolph J. Yates. "Proven devices with low revision rates might be ... the safest bet compared to new designs that have yet to be vetted in an after-market environment." ... Read more »
11 Arthroscopy/Soft Tissue Repair Companies Worth Watching
by Julie A. Vetalice | Oct 2018
We looked at funding, patent and trial/study announcements from January 2017 to June 2018 to see whose initiatives are making waves; many of these companies offer technologies that could make them acquisition or collaboration targets for large OEMs. ... Read more »
Effective Supplier Scorecards Rely on Identifying Key Metrics, Data, Inputs
by Julie A. Vetalice | Sep 2018
The correct metrics for your scorecard can include elements of quality, on time delivery, cost vs. value, and can yield actionable information. It’s not enough to collect data and see what the numbers are, though—you have to do something with it. ... Read more »
NASS Preview: 14 Spine Products That Caught Our Attention
by Julie A. Vetalice | Sep 2018
Between now and NASS 2018, we expect to hear more about new spine products that use additive manufacturing, more variations on PEEK and titanium and more expandable interbody designs. The 14 companies highlighted are already on board. ... Read more »
510(k) Recap: New Products from Companies You Know
by Julie A. Vetalice | Aug 2018
We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their growth. ... Read more »
Trauma Surgeon: Value-Based Orthopaedic Care Can Positively Impact U.S. Healthcare
by Julie A. Vetalice | Jul 2018
"The majority of devices have become commodities," says Dr. Peter Althausen. "Devices coming to market have not demonstrated improved outcomes, yet carry hefty price tags and are not affordable. Clearly there’s no winning argument to pay more for devices that do not improve outcomes." ... Read more »
Final Patient Treated in NUsurface Artificial Meniscus Trials
by Julie A. Vetalice | Jul 2018
Active Implants is pursuing an FDA De Novo 510(k) clearance for the device. If cleared, NUsurface would be the first “artificial meniscus.” ... Read more »
Zimmer Biomet Responds to FDA Form 483
by Julie A. Vetalice | Jun 2018
The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf of the investigators, a lack of context and incomplete information reported by company representatives. ... Read more »
Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies
by Julie A. Vetalice | Jun 2018
The 1H18 product launches by the top orthopaedic companies were largely focused on the market segments of spine and joint reconstruction. We offer a list of new products and their descriptions. ... Read more »
FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances
by Julie A. Vetalice | Jun 2018
To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances. ... Read more »
Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI
by Julie A. Vetalice | Apr 2018
Patrick Sweeney, M.D. is Founder of the Center for Minimally Invasive Surgery, an ambulatory surgery center in Illinois that addresses a range of orthopaedic and spinal conditions. He is also an inventor/entrepreneur, holing 30+ U.S. and European patents. ... Read more »
Smith & Nephew Names CEO with Acquisition, Turnaround Experience
by Julie A. Vetalice | Apr 2018
Mr. Namal Nawana's experience includes 15+ years with Johnson & Johnson, primarily in the Medical Devices & Diagnostics segment and culminating in 2011 with his appointment as Worldwide President of DePuy Synthes Spine. ... Read more »
by Julie A. Vetalice | Feb 2018
Over an eight-year span, the gap between the number of OEM transactions versus those in the supplier space was its narrowest in 2017. ... Read more »
Three Companies Expand Patient Engagement Offerings and Digital Tools
by Julie A. Vetalice | Nov 2017
These tools are being launched by companies that seek to remain competitive in the market as they help hospitals and surgeons improve patient outcomes and control spend. ... Read more »
New Grant to Support Device Coating Research
by Julie A. Vetalice | Nov 2017
Numerate, a drug design company applying AI to transform small molecule drug discovery, was awarded a grant by the National Institute of Arthritis and Musculoskeletal and Skin Diseases to improve outcomes for orthopaedic implant recipients. ... Read more »
Vivorte Launches New Bone Graft Products
by Julie A. Vetalice | Oct 2017
The new products round out Vivorte's offerings to provide a complete line of synthetic biomaterials. ... Read more »
Flower Orthopedics Expands Ready-For-Surgery Extremity Line
by Julie A. Vetalice | Oct 2017
Flower Orthopedics launched three new products: instruments in the Flower Efficiency (E-Kit™) Advanced system. ... Read more »
Spine Companies $100MM to $2BB: Strategic Activity Update
by Julie A. Vetalice | Sep 2017
The majority of the spine market—just about 80%—is controlled by companies with annual spine revenue above $100 million. We highlight nine of these companies here. ... Read more »
Medtronic Assumes Exclusive Commercial Rights for Mazor X
by Julie A. Vetalice | Sep 2017
Medtronic entered Phase II of its strategic partnership with Mazor Robotics, granting Medtronic exclusive global distribution of the Mazor X surgical robotic assistance platform. The partnership affords Medtronic the lead in robotics amongst the largest spine players. ... Read more »
The Fused and the Fractured: New Entrants to U.S. Spine and Trauma
by Julie A. Vetalice | Aug 2017
Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S. ... Read more »
Robotics, 3D Printing Gain Larger Adoption with Globus Medical, K2M Acquisitions
by Julie A. Vetalice | Aug 2017
In early August, both Globus Medical and K2M announced acquisitions that complement current products and position them for future growth. ... Read more »
by Julie A. Vetalice | Aug 2017
In the Knowledge Pod at OMTEC 2017, Dr. Dietz, a joint surgeon, shared his take on challenges with patient care using present systems and devices, and offered thoughts on what he’d like to see in the future. This article includes three points from Dr. Dietz’s Wish List. ... Read more »
Hip and Spine: New Players Receive FDA 510(k)s
by Julie A. Vetalice | Jul 2017
Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one interbody fusion system and a pedicle screw system. ... Read more »
by Julie A. Vetalice | Jul 2017
Zimmer Biomet announced preliminary 2Q17 overall results alongside news of the departure of David Dvorak, its CEO of ten years. Dan Florin, Senior Vice President and CFO, will serve as interim CEO. ... Read more »
Reimbursement Tips: Four Things Payors Want
by Julie A. Vetalice | Jul 2017
The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in mind—and know what you’re up against—and make good choices throughout the process. ... Read more »
Arthroscopy/Soft Tissue Technologies to Watch: 1H17 Funding Recap
by Julie A. Vetalice | Jul 2017
Funding announcements that we tracked from orthopaedic companies in 1H17 included eight arthroscopy/soft tissue-related technologies we’d like to highlight because of their novelty and early-stage backing. ... Read more »
One Answer to Your Postmarket Challenge: Planning
by Julie A. Vetalice | Dec 2016
Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start. ... Read more »
Spine Company 510(k)s from 1H16
by Julie A. Vetalice | Oct 2016
Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering. ... Read more »
Reimbursement in Spine: A NASS Priority
by Julie A. Vetalice | Sep 2016
In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline. ... Read more »
Product Spotlight: Arthroscopy and Soft Tissue Repair
by Julie A. Vetalice | May 2015
Here, we present highlights from a variety of technologies cleared and launched during 2014 and 2015 across traditional and biologic approaches. ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Mar 2014
Here we present 2013 vs. 2012 revenue for a range of orthopaedic and spine companies. Company specific performance highlights follow. ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Dec 2013
Here we present 3Q13 revenue for a range of orthopaedic and spine companies. Company specific performance highlights follow. ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Oct 2013
Here we present final 2Q13 revenue for orthopaedic and spine companies. Company specific performance highlights follow. ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Aug 2013
Revenue for companies that have reported 2Q to date is presented below. Company specific performance highlights follow. ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | May 2013
Here we present final 4Q12 and 2012 revenue for remaining companies, as well as Biomet’s latest fiscal quarter. Company specific performance highlights follow. ... Read more »
Strategic Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Apr 2013
Here we present final 4Q12 and 2012 revenue for remaining companies, as well as Biomet’s latest fiscal quarter. Exhibit 1 displays orthopaedic sales increases by product segment for 2012 vs. 2011 unless otherwise noted. Performance highlights that follow pertain to a blend of 4Q12 and 2012. ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Dec 2012
ORTHOWORLD’s estimates place 3Q12 market growth at 3% over 3Q11, as shown in Exhibit 1 on the following page. Performance highlights follow and pertain to 3Q unless otherwise noted. ... Read more »
The Global Orthopaedic Supplier Market
by Julie A. Vetalice | Dec 2012
In 2011, ORTHOWORLD estimated 2009 annual global orthopaedic supplier market sales to be ~$2 billion. At that time, slowing growth from the 2008 orthopaedic original equipment manufacturer sector was reflected in supplier side revenue. In 2010 and 2011, the supplier market commenced signs of a gentl ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Oct 2012
ORTHOWORLD’s estimates place overall 2Q12 market growth at 5% over 2Q11, as shown in Exhibit 1. Performance highlights follow and pertain to 2Q12, unless noted otherwise.Exhibit 1: Increases by Product Segment: 2Q12 vs. 2Q11 NOTES TO EXHIBIT 11 Orthopaedic products; constant cu ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Aug 2012
ORTHOWORLD’s estimates place overall 1Q12 market growth at 4% over 1Q11, as shown in Exhibit 1. Performance highlights follow and pertain to 1Q12, unless noted otherwise. Exhibit 1: Orthopaedic Sales Increases1 by Product Segment: 1Q12 vs. 1Q11 NOTES TO EXHIBIT 1 Orthopaedic products; ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Jun 2012
ORTHOWORLD’s estimates place overall 2011 market growth at 4% over 2010, as displayed in Exhibit 1. Performance highlights follow and pertain to both 4Q11 and 2011, as indicated. Exhibit 1: Orthopaedic Sales Increases1 by Product Segment: 2011 vs. 2010 Notes to Exhibit 1 Orthopaedic p ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Mar 2012
ORTHOWORLD's preliminary estimates place overall 2011 market growth at 5% over 2010, as displayed in Exhibit 1. Performance highlights follow, and address both 4Q11 and 2011, as indicated. Exhibit 1Orthopaedic Sales1 Increases by Product Segment: 2011 vs. 2010 Notes to Exhibit 1:1. Orthopaedic p ... Read more »
Company Financials: Orthopaedics and Spine
by Julie A. Vetalice | Dec 2011
ORTHOWORLD estimates place overall market growth at 5% over 3Q10, as shown in Exhibit 1, which displays orthopaedic sales growth by product segment. Performance highlights follow, and relate to 3Q unless otherwise noted. Exhibit 1: Orthopaedic Sales Increases1 by Product Segment: 3Q11 vs. 3Q10 ... Read more »
Company Financials: Orthopaedic and Spine
by Julie A. Vetalice | Oct 2011
ORTHOWORLD estimates place 2Q11 market growth at 5% over 2Q10 as shown in Exhibit 1, which displays 2Q orthopaedic sales growth by product segment for select companies. Performance highlights follow. Exhibit 1: Orthopaedic Sales1 Increases by Product Segment: 2Q11 vs. 2Q10 Notes to ... Read more »
Blogs and Apps That Bring Solutions
by Julie A. Vetalice | Oct 2011
The Vested Outsourcing blog serves several purposes, including education, comment and, of course, fun. The blog comprises four dropdown pages that include summaries of the 10 Ailments that can disrupt or derail outsourcing deals, explanations of the Five Rules or principles that guide practitioners ... Read more »
Blogs and Apps that Bring Solutions
by Julie A. Vetalice | Aug 2011
Real-time Technology Solution Manages Orthopaedic Surgery Schedules, Inventory Tracking and Implant Traceability ... Read more »
1Q11 Company Financials: Orthopaedic and Spine
by Julie A. Vetalice | Aug 2011
Here we present available company earnings for 1Q11. Our estimates place overall market growth at 4% over 1Q10, as seen in Exhibit 1, which displays 1Q orthopaedic sales growth by product segment for select companies. Performance highlights follow. Highlights pertain to 1Q11 unless otherwise noted. ... Read more »
2010 Company Financials: Orthopaedic and Spine
by Julie A. Vetalice | Jun 2011
Here are the remaining full-year performance highlights for select orthopaedic companies. We include 4Q10 revenue breakdowns where available, as well. Detail relates to full year, unless otherwise noted. Exhibit 1 displays growth by product segment. Exhibit 1: Orthopaedic Sales1 Increases by Produc ... Read more »
Blogs and Apps That Bring Solutions
by Julie A. Vetalice | Jun 2011
InVivoLink Introduces OrthoPod, a Tablet-based Implant Registry Application; Emergo Group Medical Device Blog for QA/RA Professionals; IMARC Research Blog ... Read more »
2010 Company Financials: Orthopaedic and Spine
by Julie A. Vetalice | Mar 2011
The following summarizes publicly available year over year earnings results to date. Our estimates place year over year market growth at 5% thus far, as indicated in Exhibit 1, which displays growth by product segment. Performance highlights relate to 2010, unless otherwise noted. Exhibit 1: Orthop ... Read more »
Blogs and Apps That Bring Solutions
by Julie A. Vetalice | Mar 2011
Bradshaw Medical offers its free Bradshaw Medical iPhone App; ODIN Technologies’ “Insider's BLOG from the RFID Experts”; Mobile Workforce workSmart!: Cloud-based Solution for End-to-End Control of Supply Chain; Precision Machined Products Association Blog ... Read more »
3Q10 Company Financials: Orthopaedic and Spine
by Julie A. Vetalice | Dec 2010
Following is a first look at select company financials for 3Q10. Our estimates place year over year market growth at 4%, as indicated in Exhibit 1, which displays growth by product segment. Performance highlights relate to 3Q10, unless otherwise noted. Exhibit 1: Orthopaedic Sales1 Increases by Pro ... Read more »
Review of Study Results: FDA Impact on U.S. Medical Technology Innovation
by Julie A. Vetalice | Dec 2010
FDA Impact on U.S. Medical Technology Innovation, a study released in November 2010, was undertaken to provide a view of medical technology (medtech) industry’s experiences with the current FDA environment. The study addressed the need for quantitative and qualitative data to help evaluate the imp ... Read more »
