# K212306: Tapestry Biointegrative Implant

- Pathway: 510(k) (Traditional)
- Applicant: Embody, Inc.
- Decided: Nov 2, 2021 after 102 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: 6 generations back to K850785 (1985). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201572: TAPESTRY Biointegrative Implant, Embody, Inc. (2020) Summary page 4.

## Most influential descendants
- K252647: Tapestry Biointegrative Implant (2025), 0 descendants of its own
- K220867: Tapestry Biointegrative Implant (2022), 0 descendants of its own

## 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/K212306
Methodology: https://510kreport.com/methodology