ExsoMed Gains 510(k) for NanoPhix Cannulated Lag Screw

By Julie A. Vetalice

ExsoMed Gains 510(k) for NanoPhix Cannulated Lag Screw

ExsoMed received FDA 510(k) clearance to market its NanoPhix Cannulated Lag Screw. The system provides a sterile, surgically efficient solution to optimize outcomes of common fragment fracture surgeries such as avulsion, mallet and condylar fractures.

The company claims that 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.

The NanoPhix Cannulated Lag Screw system will be available in 4Q22. Consistent with the other products in ExsoMed's portfolio, all instrumentation for NanoPhix will be sterile-packaged and single-use, for streamlined use in the operating room.

Source: ExsoMed

Product Labels: Trauma Ankle/Foot/Toe, Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory