BIOMET SEEKS TRACKING EXEMPTION FOR TOTAL TMJ IMPLANTS
This article was originally published in The Gray Sheet
Executive Summary
BIOMET SEEKS TRACKING EXEMPTION FOR TOTAL TMJ IMPLANTS in a recent letter to the agency. The Warsaw, Indiana-based firm argues that features of its total temporomandibular joint implant (TTMJ), including its biocompatible composition and high load-bearing capacity, make tracking of the device "unnecessary." FDA currently is reviewing a 510(k) for the device that was submitted on Feb. 1.