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Embody received 510(k) clearances from the Food and Drug Administration (FDA) for its TAPESTRY RC System for the treatment of rotator cuff disease. 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.
TAPESTRY RC System combines the healing benefits of the biointegrative collagen TAPESTRY implant with streamlined delivery and fully bioabsorbable anchor fixation. Photo courtesy of Embody, Inc.
The design of the TAPESTRY RC System combines an arthroscopic introducer pre-loaded with the TAPESTRY biointegrative collagen implant and the reported first fully bioabsorbable fixation anchors FDA-cleared for use for fixation in both tendon and bone in a pre-loaded anchor inserter.
The company is planning to extend its current postmarket clinical studies in shoulder arthroplasty, foot and ankle, and gluteus medius repair to further include arthroscopic rotator cuff repair.
“We believe TAPESTRY RC sets a new standard in arthroscopic rotator cuff surgery,” Jeff Conroy, CEO, Embody, said, “building on the clinical utility of TAPESTRY, now in a streamlined, all-in-one solution for arthroscopic rotator cuff surgery.”
