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Articles Tagged "trauma"

Silver-Coated Bone Screw System Receives CE Mark for Expanded Indications

by Patrick McGuire | Mar 2021

Silver Bullet Therapeutics bone screws are designed to kill bacteria in 24 hours after surgery. The company’s new CE Mark contains no anatomical, clinical or design limitations, allowing their system to be used for all orthopedic indications.... Read more »

Mediliant Acquires CTE Solutions

by BONEZONE | Mar 2021

CTE Solutions, a contract manufacturing company based in Plymouth, Indiana, is specialized in the manufacturing of spine implants.   ... Read more »

Researchers Develop New Biomaterial for Cartilage Regeneration

by BONEZONE | Feb 2021

CartiScaff largely resembles original cartilage in terms of structure and composition, and serves as a component of the regenerative tissue, thereby assisting the process or tissue formation.   ... Read more »

FDA 510(k) Recap: First Clearances for Companies in 1Q21

by BONEZONE | Feb 2021

New year, new entrants to the U.S. orthopedic market. This installation of the 510(k) recap offers up companies based in the U.S., China and Switzerland, and spans four of the major industry segments: Joint Replacement, Spine, Trauma and Sports Medicine.   ... Read more »

Combined Technologies Offer Stringent Finishing Results for Trauma Implants

by BONEZONE | Feb 2021

From intramedullary devices like nails and rods to cranial plates, there are numerous uses for trauma implants, each with its own unique surface finishing needs and requirements.... Read more »

FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway

by BONEZONE | Jan 2021

The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing against a predicate device to demonstrate equivalence.   ... Read more »

FDA 510(k) Recap: 2020 Highlights Across the Market Segments

by BONEZONE | Dec 2020

Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap relevant. Here are 10 clearances that I found to be of interest throughout 2020.   ... Read more »

Trauma Technologies Emerge to Meet the Needs of Patient Anatomy

by Patrick McGuire | Nov 2020

 A burgeoning set of small orthopedic implant companies is developing devices designed to anticipate and suit individual patients’ unique anatomy.... Read more »

Dimension Inx Raises $3.175 Million for 3D-Printed Implants

by BONEZONE | Nov 2020

The company uses a patented materials design and manufacturing platform to create 3D-printed implants for tissue repair and regeneration.   ... Read more »

Materialise Gains CE Mark Approval for Multiple Personalized Medical Devices

by BONEZONE | Nov 2020

The company expects that the CE Mark will enhance accessibility for personalized devices to become even more readily available.    ... Read more »

FDA 510(k) Recap: Companies Gain Trauma Device Clearances

by Julie A. Vetalice | Oct 2020

As the Orthopedic Trauma Association holds its Annual Meeting this week, we look at companies that seek to make a clinical difference in trauma surgery.... Read more »

3D Systems Gains FDA Clearance for Patient-Matched Surgical Guidance

by BONEZONE | Oct 2020

3D Systems’ VSP technology received 510(k) clearance as a service-based approach to personalized surgery, combining medical imaging, surgical simulation and 3D printing.   ... Read more »

RTI Surgical Gains FDA Clearance for Dynamic Active Compression Plate

by BONEZONE | Sep 2020

The zero-step titanium alloy and nitinol locking plate system provides continuous compression and torsional stability.   ... Read more »

How OIC’s Value-Based Implant Platform is Meeting the Moment During the Pandemic

by BONEZONE | Sep 2020

Long before the pandemic began upending almost everything about orthopedics and life in general, the President and Chief Executive Officer of The Orthopedic Implant Company, Itai Nemovicher, was hard at work pioneering a more affordable and transparent way to distribute implants. Now, in the context... Read more »

IlluminOss Gains FDA Clearance for Treatment of Pelvic, Clavicle and Small-Bone Fractures

by BONEZONE | Jul 2020

The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market.   ... Read more »

FDA 510(k) Recap: Lesser-Known Companies and First Orthopedic Clearances

by Julie A. Vetalice | Jun 2020

FDA cleared 40 orthopedic products in May. We highlight four companies that may be new names to you as well as their technology. ... Read more »

FDA-Cleared Navigation, Planning and Robotic Systems

by Julie A. Vetalice | Feb 2020

Enabling technology will be a large focus in 2020. In preparation for announcements to come, we took stock of FDA 510(k) cleared products from 2018 to 2019.... Read more »

Studies Show that Silk Fibroin Material May be Suitable for Interlocking Nails

by BONEZONE | Jan 2020

Silk protein fiber is 75% biocompatible fibroin that has multiple applications in the medical field.   ... 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 BONEZONE | 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 »

Conventus Orthopaedics Acquires Intramedullary Technology from IntraFuse

by BONEZONE | 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 »

4 New Technologies in Spine, Joint Replacement, Trauma, Sports Medicine

by BONEZONE | 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 »

Infographic: Top 10 Orthopedic Trauma Companies

by BONEZONE | Nov 2019

DePuy Synthes and Stryker combined hold more than 50% of the market share in the $7 billion+ trauma segment.... Read more »

Elos Medtech Onyx U.S. Production Facility Expansion

by BONEZONE | Nov 2019

The company recently doubled its manufacturing space, increasing capacity to support customers in the global orthopedic market.   ... Read more »

Stryker Boosts Extremities Portfolio with Wright Medical Acquisition

by Mike Evers | Nov 2019

Stryker entered a definitive agreement to purchase Wright Medical, speeding the company's path to leadership in extremities. ... Read more »

WishBone Medical Enters Global Distribution Agreement with Optimal

by BONEZONE | Oct 2019

WishBone Medical signed an agreement with logistics company Optimal, supporting global distribution of single-use, sterile packed orthopedic implants for pediatric applications.   ... Read more »

DePuy Synthes to Promote TINAVI Robotic Solutions in China

by BONEZONE | Oct 2019

Together, the companies will jointly promote the rapid development of digital surgery and technological medical innovation, providing insights for the Chinese medical industry through local collaboration and optimizing patient experience.  ... Read more »

Bactiguard to License Infection Prevention Coating to Zimmer Biomet

by BONEZONE | Sep 2019

Bactiguard will apply anti-infection technology to Zimmer Biomet's devices for fracture repair.   ... Read more »

Trauma: A Regulatory and Product Launch Recap

by BONEZONE | 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 »

X-BOLT Introduces New Hip Fracture Concept

by BONEZONE | Sep 2019

X-BOLT Orthopaedics addresses the issue of screw cutout in hip fracture repair with technology that replaces the lag screw for femoral head fixation. Studies indicate that the system significantly reduces the reoperation rate.  ... Read more »

Carolina Precision Technologies Acquires Renchel Tool

by BONEZONE | Sep 2019

Renchel Tool focuses on complex orthopedic instruments and implants as well as aerospace/petro-chemical applications.   ... Read more »

Onkos Surgical’s Personalized Approach to Treating Musculoskeletal Cancers

by Heather Tunstall | Jun 2019

Onkos Surgical targets underserved oncology surgical market with an expanding portfolio of implants and technology.... Read more »

Exactech Acquires EPIC Extremity, Trauma Device Company

by BONEZONE | 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 BONEZONE | 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 »

HealthpointCapital Acquires Majority Stake in CrossRoads Extremity Systems

by BONEZONE | May 2019

The investment supports growth of CrossRoads' Active Stabilization portfolio of lower-extremity implant systems for orthopedic and podiatric surgeons.  ... Read more »

Orthopedic Pediatric Companies Receive Funding from Pitch Competition

by Kim Snell | May 2019

Orthopedic pediatric care gained recognition with a funding pitch competition that granted five winners $50,000 to support commercialization.... Read more »

In2Bones Launches TriWay TTC Nail Arthrodesis System and Soft Tissue Release System

by BONEZONE | 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 »

OrthoPediatrics/CoorsTek Medical Licensing Partnership

by BONEZONE | May 2019

The technology sublicense may have use in existing systems and future projects in development.   ... Read more »

FDA 510(k) Recap: Adjacent Markets, Additive, Surgical Platforms

by BONEZONE | 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 »

CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew

by BONEZONE | 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 »

FDA 510(k) Recap: AQrate, ROSA and First Clearances

by BONEZONE | 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 BONEZONE | 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 »

FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019

by BONEZONE | 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 »

Kyocera Expands U.S. Business with Purchase of Renovis Surgical Technologies Assets

by BONEZONE | Jan 2019

Renovis Surgical Technologies is a developer of hip and knee joint reconstruction, spinal and trauma devices. The transaction complements U.S. sales of Kyocera’s own FDA-cleared total hip devices and grants the company access to spine products—a segment in which it formerly did not operate.... Read more »

Year in Review: Orthopaedic Companies New on Our Radar in 2018

by BONEZONE | 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 »

In2Bones: 4Q18 Product Launches Focus on Fracture Repair, Foot Deformities

by BONEZONE | Dec 2018

These three products include a transparent PEEK implant for pediatric and adult flat foot deformity; titanium-alloy bone plates, also featuring a transparent PEEK hub and a plating system for ankle fracture repair/ osteotomies.... Read more »

DePuy Synthes: A Look at PUREVUE and 2018 Product Launches

by BONEZONE | Dec 2018

The PUREVUE™ Visualization imaging platform, now available globally, has application in minimally invasive endoscopic surgery. We also recap the company’s product launches in arthroscopy/soft tissue, joint replacement, spine and trauma.... Read more »

Trauma Surgeon: Value-Based Orthopaedic Care Can Positively Impact U.S. Healthcare

by BONEZONE | 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 »

206 Ortho Secures Patent for Technology That Incorporates Biodegradable Material

by BONEZONE | Jul 2018

The company has developed a bio-inspired non-metallic composite and implants made with a high-strength, biodegradable material intended to repair load-bearing bone and resorb completely. 206 Ortho is pursuing additional funding and potential commercialization partners.... Read more »

Year-to-Date Funding Recap: Robotics, Imaging, ACL Implant, Cervical Disc and More

by BONEZONE | Jul 2018

These funding announcements feature technologies related to each of the market segments: spine, trauma, arthroscopy/soft tissue, joint reconstruction and orthobiologics.... Read more »

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

by BONEZONE | Jul 2018

A review of patent activity in 1H18 shows technological innovations from companies like Episurf, iOrthopedics, Orthocell and Spineology across arthroscopy/soft tissue repair, joint reconstruction, orthobiologics, spine and trauma.... Read more »

Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies

by Julie 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 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 »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by BONEZONE | Jun 2018

Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images.... Read more »

Orthopaedic Industry Reaches $49.3 Billion, Grows 3.7%

by BONEZONE | May 2018

Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »

Scientists Successfully Test New Titanium Plate for Bone Tissue Repair

by BONEZONE | Apr 2018

In animal testing, the patented titanium fiber plates did not demonstrate bone embrittlement after close contact for prolonged periods.... Read more »

Globus Medical Making Sizable Push Into Trauma Market

by BONEZONE | Mar 2018

The company debuted its suite of FDA-510(k)-cleared trauma products in four families at the 2018 American Academy of Orthopaedic Surgeons annual meeting.... Read more »

AcceLINX Adding Three Experts to Consultant Roster, Collaborating With AMB Surgical

by BONEZONE | Mar 2018

The musculoskeletal health business accelerator adds expertise focused on manufacturing/operations, reimbursement and grant writing.... Read more »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Mar 2018

Increased infection rates at hospitals, regulatory implications on cleaning and the efforts of hospitals to cut costs have all driven sterilization changes in device packaging.... Read more »

Examining Critical Trends in Trauma Surgery

by BONEZONE | Nov 2017

Complex fractures and complications from fractures are challenging trauma surgeons’ views on periprosthetic fractures, infection prevention, weight-bearing recommendations and percutaneous pelvic fractures.... Read more »

Bone Biologics Targets Spine Fusion with UCLA License Agreement

by BONEZONE | Sep 2017

Bone Biologics entered into an exclusive license agreement with UCLA for global application of NELL-1/DBX® protein in the treatment of osteoporosis and trauma through a technology transfer.... Read more »

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

by Julie 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 »

Infection Prevention Spurs New R&D Ideas

by BONEZONE | Jun 2017

Post-surgical infection control remains a topic of importance in orthopaedic product development, as surgeons, researchers and device companies continually seek to reduce complications, readmissions, revisions and cost. The sense of priority was validated at OMTEC® 2017, when these groups met to ad... Read more »

May 510(k) Review: New Players in SI Joint Fusion, Hip Recon

by BONEZONE | Jun 2017

Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen meniscus repair implant, SI joint fusion device and new total hip.... Read more »

R&D Recap: Leading Orthopaedic Device Company Product Initiatives

by BONEZONE | Jun 2017

Acquisitions, divestitures, market entries and exits have contributed to the shaping of product portfolios of the orthopaedic industry’s larger players, in recent years. We review their product development initiatives over the last 18 months to offer a good look at your competitors’ strateg... Read more »

2016: The Year in Products and Services

by BONEZONE | Dec 2016

What are you working on for 2017? How do your daily tasks align with overall growth objectives? We look forward to sharing your successes in these pages next year. Until then, let’s reflect on what fueled momentum this year.... Read more »

Clinical Data: A Snapshot of Recent Announcements

by BONEZONE | Nov 2016

Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know ... Read more »

New Trauma Technologies Emerge to Treat Infections

by BONEZONE | Jul 2016

Infection control has been on the radar of various orthopaedic device companies, from start-up to top five. In the trauma market, technologies intended to minimize post-surgical infections are emerging as a potential solution to curb rising healthcare costs.... Read more »

A Look into Trauma Trends: Surgeon and Industry Perspective

by Hannah Corcoran | Dec 2015

According to surgeons and industry interviewed by BONEZONE, trends in trauma center on the rise in hip fractures, challenges of treating osteoporosis and pelvis fractures, the emergence and need for specialty plates and a place for biologics to enhance bone healing.... Read more »