ExsoMed Gets 510(k) Clearance for its NanoPhix System

Aliso Viejo, Calif.-based ExsoMed has received 510(k) clearance from the FDA for its NanoPhix guided compression-screw system for use in hand fracture surgeries.

The lag screw system, which offers surgeons a sterile way to repair common fragment fractures, features a 1.5 mm-diameter design with cannulation for stable fixation of small fracture fragments. The system is designed to enable hand surgeons to properly place the screw tip to avoid skiving off the bone.

ExsoMed said it plans to launch the product on the U.S. market in the fourth quarter of 2022. All the instrumentation for the system will be sterile and single use, the company said.