Approvals, clearances, designations

Solenic Medical, developer of a device using alternating magnetic fields to treat prosthetic joint infections (PJI), received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The patent-pending technology exclusively licensed from University of Texas Southwestern Medical Center offers a non-invasive approach to eradicate biofilm on metallic implants and treat PJI. Initially targeting the metallic components of knee implants, this product is the first in the company’s pipeline of treatments for most metallic medical implants including knees, hips, elbows, and trauma devices.
https://www.solenic.com

Nextremity Solutions Inc., received 510(k) clearance to market its upcoming Stratum RS (Reduced Size) Foot Plating System. Building on the success of the Stratum Foot Plating System that launched in 2019, the system includes 18 different plates designed to fit various anatomies in smaller patients. This includes Single Lisfranc, Peanut, Straight, Hockey Stick, L-shaped, Y-shaped, and T-shaped plates. This expansion of the Stratum brand will result in nearly 70 options to treat foot deformities and fractures. The system also includes a single-use disposable instrument kit that eliminates the need for sterilization by hospitals, and provides surgeons with brand new instrumentation for every case. https://www.nextremity.com