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Trauma: A Regulatory and Product Launch Recap

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 of smaller companies, we’ve highlighted announcements from 10.   

     


3 Questions with OTA’s Program Chair

The symposiums held at surgeon society meetings highlight important topics of the day, providing device company professionals with insight into surgeons’ most significant interests. When the Orthopaedic Trauma Association hosts its 35th annual meeting this year, the four symposiums will include discussions on limb salvage vs. amputation, approaches to hemodynamically unstable pelvic ring injuries, fracture-related infections and a challenge to traditional thinking about evidence from recent trials.

We were particularly interested in the latter two topics. We asked Michael J. Gardner, M.D., Chief of Orthopaedic Trauma Service and Vice Chair of Clinical Operations at Stanford University, as well as Program Chair for the annual meeting, to expand on the purpose of these topics today.

What are the current challenges and opportunities to prevent post-op infections? How are hospitals/surgeons prioritizing infection as an issue to tackle?

Dr. Gardner: Despite incredible technological advances over the last few decades, we haven’t made substantial progress in preventing postoperative infections. The main challenges include improving patient host issues, effective debridement assessment of persistent microbials or necrotic tissue, and dealing with biofilm in orthopedic implants. Hospitals in general are prioritizing this, I believe; however, much more research is needed for effective strategies.

Another main symposium will focus on recent dogma-changing evidence in orthopedic trauma. What do you mean by that, and how will it be addressed at the Annual Meeting?

Dr. Gardner: Dogma relates to the standard way that we treat different issues in orthopedic trauma. Many of these approaches get passed on through generations of trainees because they are “just the way we always do it,” without good evidence to support these practices. In the past decade, there has been a focus on performing high-quality trials to determine the best evidence-based approaches for treatment. During this session at the OTA Annual Meeting, we will review recent evidence that may potentially change the way that orthopedic trauma surgeons practice.

Our readership is primarily orthopedic device company professionals, such as those that exhibit at the Annual Meeting. What would you share with them about clinical priorities or product development?

Dr. Gardner: The main thing that I would say is that there really is so much to be learned still about the best way to treat a vast number of issues in orthopedic trauma. Given the current landscape in academic medicine, surgeons increasingly rely upon industry to help fund research efforts and this is extremely appreciated by all in the orthopedic community. – Heather Tunstall

   


REGULATORY

Additive Orthopaedics received FDA 510(k) clearance to market Patient Specific 3D Printed Locking Lattice Plates to address stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. Patient specific implants, such as this newly-cleared product and Patient Specific 3D Printed Bone Segments, serve as the cornerstone of Game Plan™, an integrated surgical planning system.

AMDT Holdings was granted FDA 510(k) clearance to market the SixFix™ hexapod fixator device (pictured above) along with its SixFix deformity analysis and correction software (DACS) application. The six struts of the device are pre-assembled in one compact unit. The strut assembly design can extend to 300mm in length, offering an alternative that simplifies inventory and saves time. The device can be sterile packaged for ease of storage and portability. Used with SixFix DACS software, the system can streamline the time and effort required to generate a prescription detailing the strut adjustments necessary to correct a deformity.

CurvaFix received FDA 510(k) clearance to market the CurvaFix® Intramedullary Rodscrew for pelvic trauma surgery. The flexible device is implanted through a small incision into the intramedullary space, then converted into a rigid state to stabilize and repair the fracture. The CurvaFix Rodscrew is reportedly the only intramedullary implant capable of following the natural bone shape of curved bones, such as the pelvis.

Nvision Biomedical Technologies received FDA 510(k) clearance to market Vector™, the first foot/ankle implant made from PEEK-OPTIMA™ HA Enhanced polymer. The device is also reportedly the first lower extremity implant to use Structural Encoding® to enable Unique Device Identification. Structural Encoding is able to embed the entire history of the device; this data can be read by simple x-ray imaging. This clearance represents Nvision’s entry to the extremities trauma market, expanding from its previous focus on spine.

Metalogix was granted FDA 510(k) clearance for the Revolution External Plating System, open ring fixation for long bone fractures, limb lengthening and bone deformity correction. The all-in-one system can treat long bone trauma, Charcot, foot and ankle, congenital deformities and pelvic trauma, and is indicated for adult and pediatric subgroups (except newborns).

OSSIO received FDA 510(k) clearance to market OSSIOfiber™ bone pins, made of a proprietary bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind. First commercial use occurred in the treatment of forefoot conditions, though the platform will have broad application across orthopaedics, including distal extremities, trauma, sports medicine, reconstruction, pediatrics and spine in the form of pins, screws and plates.


PRODUCT LAUNCHES

Biedermann Motech introduced the Distal Radius 2.0 Plating System and the MDS Injection Screw. All Biedermann Motech fracture fixation devices feature Next Generation Polyaxial Locking Technology®, which supports 40° polyaxial locking, consistent locking at every angle, compression with every screw before locking and an all-titanium, low profile construct. The Distal Radius 2.0 Plating System offers 45° polyaxial locking, as well as 2.0mm screws and 1.8mm pegs distally. The MDS Injection Screw is reportedly the first and only polyaxial locking injection screw that is cleared for use in the U.S. It works with MDS Humeral Plating Systems to deliver injectable bone void fillers to a surgical site.

Flower Orthopedics increased the footprint of its Ready-for-Surgery™ portfolio with launch of the Flower Jones Screw and a 6.5mm Headless Compression Screw. FlowerCube is a single-use, sterile implant and instrument system for foot and ankle surgery. Each product is ready to use and tailored for each specific procedure. With up to two instrument kits, surgeons can address multiple indications that now include Jones fracture repairs and complex rearfoot procedures with this latest launch.

IlluminOss Medical commenced U.S. launch of the IlluminOss® Bone Stabilization System to treat traumatic and fragility fractures of the humerus, radius and ulna. IlluminOss received its initial de novo FDA clearance in 4Q17 for fractures associated with metastatic bone; FDA 510(k) clearance for traumatic and fragility fractures was received in 3Q18. The procedure uses a light-curable liquid monomer, contained within an expandable PET balloon catheter, to achieve stabilization in poor quality/compromised bone. This is delivered through a small percutaneous incision. Once the implant is cured and polymerized, it conforms to the geometry of a patient’s intramedullary canal.

WishBone Medical is debuting an array of new products with global launch of its pediatric foot and ankle systems. The platform includes the AlloMate Bone Pin, Foot and Ankle K-Wire Kits and a full plating system to fix juvenile bunions, flatfoot, fractures, etc. Unlike devices built for adult anatomies, WishBone’s designs avoid growth plates and growth interruption. The sterile-packed, disposable implants and instruments reduce infection risk and are appropriate for any surgical setting, including ambulatory surgery centers.

This email address is being protected from spambots. You need JavaScript enabled to view it. is ORTHOWORLD’s Editorial Assistant.

 

 

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