ExsoMed Corporation Announces FDA 510(k) Clearance of the NanoPhix™ Cannulated Lag Screw System for Fracture Fragments

Friday, April 29, 2022

ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize its NanoPhix Cannulated Lag Screw system. The cannulated lag screw provides surgeons with a sterile, surgically efficient solution to optimize outcomes of common fragment fracture surgeries such as avulsion, mallet, and condylar fractures.

Treatment of small, fracture fragments continues to be a frustration for hand surgeons because it is difficult to achieve proper placement of the screw tip and avoid skiving. Most modern fixation options do not offer the right balance of implant cannulation and sizing, also requiring a complicated surgical technique, which can cause additional comminution to the existing fracture. NanoPhix is the first and only implant to provide a 1.5mm diameter design with cannulation to achieve stable fixation of small fracture fragments with surgical efficiency, in a sterile-packaged system that is ready for immediate use.

"Surgeons have shared with us their desire for a lag screw system that actually works," said James Young Kim, ExsoMed's Chief Marketing Officer. "Current solutions in the marketplace have fallen short of surgeon demands, specifically from a surgical technique and ease of use perspective. NanoPhix and ExsoMed's innovative dual guidewire delivery mechanism will enable hand surgeons to further address those issues encountered during cases and help improve surgical efficiencies and most importantly, patient outcomes."

"NanoPhix is the first ever guided compression screw that allows targeting of the distal cortex," said Lloyd Champagne, MD of Arizona Center for Hand to Shoulder Surgery, based in Phoenix, AZ. "I'm so excited about this technology because it increases accuracy of cannulated fragment fixation, while keeping things super simple for me intra-op. This is a technology that I've been very much looking forward to using."

The NanoPhix Cannulated Lag Screw system will be available in the fourth quarter of 2022. Surgeon education and training opportunities will begin rolling out in the Fall. Consistent with the other products in ExsoMed's portfolio, all instrumentation for NanoPhix will be sterile-packaged and single-use, for stream-lined use in the operating room.

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