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 »
CTE Solutions, a contract manufacturing company based in Plymouth, Indiana, is specialized in the manufacturing of spine implants. ... Read more »
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 »
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 »
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 »
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 »
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 »
A burgeoning set of small orthopedic implant companies is developing devices designed to anticipate and suit individual patients’ unique anatomy.... Read more »
The company uses a patented materials design and manufacturing platform to create 3D-printed implants for tissue repair and regeneration. ... Read more »
The company expects that the CE Mark will enhance accessibility for personalized devices to become even more readily available. ... Read more »
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’ VSP technology received 510(k) clearance as a service-based approach to personalized surgery, combining medical imaging, surgical simulation and 3D printing. ... Read more »
The zero-step titanium alloy and nitinol locking plate system provides continuous compression and torsional stability. ... Read more »
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 »
The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market. ... Read more »
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 »
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 »
Silk protein fiber is 75% biocompatible fibroin that has multiple applications in the medical field. ... Read more »
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 »
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 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 »
Small and mid-sized orthopedic companies bolstered their portfolios at year-end with products to help grow revenue in the coming year. ... Read more »
DePuy Synthes and Stryker combined hold more than 50% of the market share in the $7 billion+ trauma segment.... Read more »
The company recently doubled its manufacturing space, increasing capacity to support customers in the global orthopedic market. ... Read more »
Stryker entered a definitive agreement to purchase Wright Medical, speeding the company's path to leadership in extremities. ... Read more »
WishBone Medical signed an agreement with logistics company Optimal, supporting global distribution of single-use, sterile packed orthopedic implants for pediatric applications. ... Read more »
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 will apply anti-infection technology to Zimmer Biomet's devices for fracture repair. ... Read more »
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 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 »
Renchel Tool focuses on complex orthopedic instruments and implants as well as aerospace/petro-chemical applications. ... Read more »
Onkos Surgical targets underserved oncology surgical market with an expanding portfolio of implants and technology.... Read more »
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 »
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 »
The investment supports growth of CrossRoads' Active Stabilization portfolio of lower-extremity implant systems for orthopedic and podiatric surgeons. ... Read more »
Orthopedic pediatric care gained recognition with a funding pitch competition that granted five winners $50,000 to support commercialization.... Read more »
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 »
The technology sublicense may have use in existing systems and future projects in development. ... Read more »
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 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 »
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 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 »
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 »
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 »
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 »
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 »
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 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 »
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 »
These funding announcements feature technologies related to each of the market segments: spine, trauma, arthroscopy/soft tissue, joint reconstruction and orthobiologics.... 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 »
Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images.... Read more »
Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »
In animal testing, the patented titanium fiber plates did not demonstrate bone embrittlement after close contact for prolonged periods.... Read more »
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 »
The musculoskeletal health business accelerator adds expertise focused on manufacturing/operations, reimbursement and grant writing.... 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 »
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 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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
