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, and additive manufacturi... Read more »
MiRus received FDA 510(k) clearance for Europa, a pedicle screw made with MoRe®, a proprietary molybdenum rhenium superalloy expected to provide more strength, ductility and durability than titanium and cobalt. ... Read more »
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 »
Testing labs and manufacturers will benefit from the specification of good practices for inspection and failure documentation. ... Read more »
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 »
EU MDR planning is a classic project management activity to identify what has to be done, in what order, by whom and by when, and how progress will be monitored. Every project will vary...it's not possible to create one implementation plan applicable to all organizations.
This paper offers guidance... Read more »
The interbody fusion device is reportedly the first non-metal lumbar cage made in Japan. ... Read more »
HiJak addresses complex cervical conditions, and can adjust both height and lordosis to restore balanced sagittal alignment. ... Read more »
Orthopedic joint replacement and spine companies tout their coatings as essential elements to new products.... Read more »
As the orthopedic industry places greater emphasis on surgical site infection, one spine company touts a system that impedes all pedicle screw contact.... Read more »
Renishaw collaborated with Irish Manufacturing Research and nTopology to demonstrate the advantages of additive manufacturing in the production of spinal implants.... Read more »
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 »
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 »
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 »
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 »
Additive manufacturing software company Betatype significantly increased the production of 3D-printed metal orthopaedic implants using its technology platform and Renishaw’s RenAM 500Q powder bed fusion printer.... Read more »
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 »
ARAI is an augmented reality and artificial intelligence-based surgical navigation system that provides real-time patient-specific 3D anatomical visualization for pre-op planning, real-time intra-op guidance and post-op data analytics.... Read more »
What else did you read about the most on our website last year? Arthroscopy/soft tissues companies to watch; products in spine, knee and hip; surgeon perspectives on implant material choice; supply chain quality; labelling mistakes, Brazil and more. ... Read more »
The previously announced purchase demonstrates Medtronic’s belief in the future of guided spinal procedures. Mazor joins Medtronic’s Neurosurgery business, part of the Restorative Therapies Group’s Brain Therapies division.... Read more »
Alok D. Sharan, M.D., shares how he started performing one-level lumbar spine fusion while patients are awake and offers product development considerations to device companies. “We believe that we’ve completely transformed the experience of spinal fusion surgery,” Dr. Sharan says.... Read more »
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 »
UPI is a contract manufacturer specializing in instruments and guide wires, primarily for spine.... Read more »
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 »
The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials and manufacturing.... Read more »
Medtronic, DePuy Synthes, Stryker and Globus Medical—four of the five largest spine companies ranked by revenue—announced acquisitions in the last month. We recap the additions to their product portfolios.... Read more »
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 »
Orthopaedic professionals can expect to hear about technologies being commercialized by 22 companies along with insight from long-term investors during the conference, held October 23-24 in Memphis, Tennessee.... Read more »
K2M’s innovative technology platform will add a suite of complex spine solutions to Stryker’s core spine portfolio; K2M’s consistent support of additive manufacturing of devices could also benefit Stryker’s long-term growth.... Read more »
The company was formed by Genesis Innovation Group with investments from cultivate(MD) Capital Funds I and II, and is based on the work of Ryan K. Roeder, Ph.D., and researchers from the University of Notre Dame that began over 10 years ago.... Read more »
P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation. Cerapedics has enrolled the first of 364 patients in this IDE clinical trial.... Read more »
"Cage design has been a game changer in spine surgery." Three veteran spine surgeons provide insight into the shift to titanium, a forecast for the next five years in cage technology and thoughts on device companies' priorities.... Read more »
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 »
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 »
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 »
We examine the players and products, address data and adoption, and look at who is driving the push toward the technology.... Read more »
Chad Herremans and Nathan White join the company in VP roles.... Read more »
These two developments could assist Paradigm Spine in adoption of its novel product that has faced reimbursement hurdles.... Read more »
Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »
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 »
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 »
Dr. Kornelis Poelstra's researcn shows that molybdenum-rhenium (MoRe) offers greater strength in smaller implants compared to cobalt-chrome, titanium and stainless steel.... Read more »
Zyga Technology is the developer of the SImmetry® Sacroiliac Joint Fusion system.... Read more »
With its first application in minimally invasive spine procedures, X-VISION technology is designed to save time during surgery, reduce radiation exposure and reduce the number of repeat operations and hospitalizations.... Read more »
This is reportedly the first PEEK-OPTIMA HA vertebral body replacement to receive FDA clearance.... Read more »
Oxford Performance Materials says that study results reveal superior antibacterial properties of PEKK structures compared to PEEK surfaces.... Read more »
We highlight recent clinical trial results, a procedural milestone and a device launch.... Read more »
In response to spine surgeons’ shift away from traditional PEEK cages, materials were (again) one of the main themes discussed at the North American Spine Society Annual Meeting. At NASS, we sat down with representatives of companies promoting osteoconductive PEEK and molybdenum-rhenium.... Read more »
The system received FDA 510(k) clearance in December 2016.... Read more »
Companies announced numerous spine product regulatory decisions and market launches well in advance of the 2017 NASS Annual Meeting. We've recapped product updates as a guide for what you can see and hear about on the exhibit floor.... Read more »
Minimally invasive surgical (MIS) products are a staple of today’s spine company portfolios. In anticipation of new devices to be launched at the NASS Annual Meeting, we asked James F. Marino, M.D. about the technologies.... Read more »
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 »
Nearly 100 suppliers are expected to exhibit at NASS 2017. As you decide whom to meet with on the exhibit floor, we thought you might have the same question we did for these companies: Why?... Read more »
In preparation for attending the NASS Annual Meeting in October, we took time to speak to supplier and service provider companies to get a read on current trends and future advancements in spine.... Read more »
Centinel Spine has entered into an agreement to purchase DePuy Synthes’ worldwide prodisc assets. The acquisition is expected to close in mid-4Q17. Terms were not disclosed.... Read more »
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 »
Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and orthopaedic surgery.... Read more »
Alphatec Spine posted 2Q17 revenue of $24.4MM, -24.4% vs. 2Q16, and 1H17 revenue of $52.4MM, -21.2% vs. 1H16. Though revenues continue to underperform vs. the prior year, leadership sees substantial opportunities for turnaround.... Read more »
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 »
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 »
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 »
3D Systems released Simbionix SPINE Mentor, a hands-on simulated training and practice tool for minimally invasive spine surgeries.... Read more »
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 »
Orthopaedic industry revenue reached $48.1 billion worldwide in 2016 and grew at 3.2%, ~$1.5 billion over 2015, according to our estimates published in the ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. ... Read more »
ChoiceSpine expands breadth of product and global distribution with acquisition.... Read more »
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 »
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 »
In preparation for NASS, we spoke with Executive Director and CEO Eric Muehlbauer and Christopher M. Bono, M.D., President of NASS. Both discussed reimbursement matters—a concern for surgeons and device manufacturers alike. What else was on the President’s mind?... Read more »
Researchers at The University of New South Wales developed a fusion device designed to stabilize the spine without bone graft or pedicle screws in single-level posterolateral fusion.... Read more »
During 2015, the company invested $1.7 million in a 15,000-square-foot facility and supported the creation of 15 new jobs.... Read more »
In speaking with Eric Muehlbauer, Executive Director and CEO of NASS about the Society's priorities, as well as where the greatest opportunities lie for surgeons and device companies, three topics arose.... Read more »
Approximately $3.2MM will support establishment of commercial operations in Austin, Texas.... Read more »
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 »
NASS 2016 welcomes more than 70 suppliers to its exhibit floor. Use this list to identify your next new partner.... Read more »
In efforts to invigorate revenue growth, Medtronic and Zimmer Biomet have focused on niche technologies that expand their portfolios—but have yet to prove wide scale adoption.... Read more »
The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe.... Read more »
Poly-Shape, a French manufacturing company specializing in laser sintering, entered into an exclusive agreement with LDR. The agreement combines LDR’s spinal focus and approach to implant design with Poly-Shape’s proprietary, additive manufacturing methods.
The agreement was signed in 4... Read more »
Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Spine surgeons discuss trends that excite them, their biggest challenges when using devices and what they want you to know when working with them to collectively improve spinal care.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
