Cornwall Hospital

Embody, Inc. Announces 510(k) Clearances for TAPESTRY® RC for Rotator Cuff Repair

Retrieved on: 
Tuesday, May 31, 2022
Foot, Pain, Food, Medicine, Ligament, Multimedia, Patient, DOD, Northwell Health, View, Sports medicine, Failure, DARPA, FDA, Rotator cuff, Food and Drug Administration, Luke the Evangelist, United, Ankle, MD, Cornwall Hospital, Hospital, Embodiment

NORFOLK, Va., May 31, 2022 /PRNewswire/ -- Embody, Inc., a privately-held medical device company focused on soft tissue healing, announced today that it has received 510(k) clearances from the Food and Drug Administration (FDA) for its TAPESTRY RC System for the treatment of rotator cuff disease. Uniquely designed for arthroscopic procedures, TAPESTRY RC System combines the healing benefits of the biointegrative collagen TAPESTRY implant with streamlined delivery and fully bioabsorbable anchor fixation.

Key Points: 
  • In 2021, there were an estimated 670,000 rotator cuff repairs in the United States.1 The goal of rotator cuff surgery is to repair the damaged tendon and restore mobility for patients.
  • "We believe TAPESTRY RC sets a new standard in arthroscopic rotator cuff surgery,"said Jeff Conroy, Chief Executive Officer of Embody.
  • "Building on the clinical utility of TAPESTRY, now in a streamlined, all-in-one solution for arthroscopic rotator cuff surgery."
  • "Embody's TAPESTRY RC System allows for efficient and versatile delivery in a fully bioabsorbable solution to biologic augmentation of the rotator cuff in arthroscopic procedures."