# K252647: Tapestry Biointegrative Implant

- Pathway: 510(k) (Special)
- Applicant: Embody, Inc.
- Decided: Sep 19, 2025 after 29 days
- Product code: OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K850785 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212306: Tapestry Biointegrative Implant, Embody, Inc. (2021) Summary page 5.

## Indications for use
Tapestry Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K252647
Methodology: https://510kreport.com/methodology