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Revenue, Episealer and Metal-on-Metal Top February News

What ORTHOFLASH news was the most popular during February?

Financial reviews:

Year-end and full-year revenues for CONMED, DePuy Synthes, Smith & Nephew, Stryker and Zimmer Biomet, while primarily published in January, topped the clicks in February. Of these, more users accessed DePuy Synthes than any other revenue recap—but of financials, readers spent the most time absorbing Zimmer Biomet’s results.


Study results: Episealer may stop or significantly slow the process leading to OA

Study results suggest that a permanent bond may form between cartilage and the hydroxyapatite coating of Episurf’s Episealer® device, suggesting that implantation of Episealer may stop or significantly slow the process that leads to osteoarthritis. This is reported to be the first time that such results have been shown, clinically.


FDA Issues Final Order on PMAs for Metal-on-Metal Hips

FDA issued a final order requiring OEMs to submit a premarket approval application for certain metal-on-metal total hip replacement devices, believing that there is insufficient evidence to conclude that general and special controls would provide reasonable assurance of the devices’ safety and effectiveness.


Zimmer Biomet Receives FDA 510(k) Clearance for Unite3D Bridge Fixation System

This 3D-printed technology is designed for use in foot and ankle arthrodesis. Unite3D is made from OsseoTi® porous metal technology, which mimics the structure of cancellous bone.


Tyber Medical Launches TyWedge Evans and Cotton Osteotomy Wedge Systems

This represents full market launch for these systems that feature TyPEEK® proprietary titanium plasma-sprayed PEEK coating, which is specifically indicated for fusion. Tyber Medical's portfolio now spans >26,000 product configurations contained across 15 product lines.