FDA Clears Embody’s Tapestry RC for Rotator Cuff Repair

Embody has received a 510(k) clearance from the FDA for its Tapestry RC system for use in arthroscopic procedures for treatment of rotator cuff injuries.

Designed for streamlined arthroscopic delivery, the device is a collagen implant with a fully bioabsorbable anchor fixation.

Norfolk, Va.-based Embody specializes in collagen-based products for the sports medicine market. With the launch of Tapestry RC, the company said it will extend its postmarket clinical studies in shoulder arthroplasty, foot and ankle repair to include arthroscopic rotator cuff repair.

An estimated 670,000 rotator cuff repairs were performed in the U.S. in 2021, according to Embody.