Embody, Inc. announces that it has received U.S. FDA 510(k) clearance for its Tapestry RC system for rotator cuff repair.
Embody is a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair. They are seeking to improve future of rotator cuff repair by combining a biointegrative collagen implant with streamlined arthroscopic delivery and fully bioabsorbable anchor fixation. 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. However, failure can occur due to inadequate healing of the soft tissue, resulting in pain, loss of function and costly reoperations.
“We believe Tapestry RC sets a new standard in arthroscopic rotator cuff surgery,” says Jeff Conroy, CEO of Embody. “Building on the clinical utility of Tapestry, now in a streamlined, all-in-one solution for arthroscopic rotator cuff surgery.”
The novel design of the Tapestry RC System combines an arthroscopic introducer pre-loaded with the Tapestry biointegrative collagen implant and the first fully bioabsorbable fixation anchors FDA cleared for use for fixation in both tendon and bone in an easy-to-use, pre-loaded anchor inserter.
Embody is a portfolio company of Genesis Innovation Group.
“Genesis Innovation Group and the cultivate(MD) venture capital fund have been proud to work alongside Jeff Conroy and his team at Embody since 2019 to develop what we believe to be an industry best deployment and fixation system with the Tapestry RC System. We are excited about what this 510(k) Clearance represents for the future of Embody,” says Genesis Innovation Group’s Executive Director, R. Sean Churchill, MD, MBA.
Embody is planning to extend its current post market clinical studies in shoulder arthroplasty, foot and ankle, and gluteus medius repair to further include arthroscopic rotator cuff repair.
References
1.BIOMEDGPS 2022. SmartTRAK Soft Tissue Augmentation
