# K080452: Collagen Tendon Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: May 15, 2008 after 86 days
- Product code: FTM (Mesh, Surgical)
- 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: 3 generations back to K850785 (1985). 8 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053655: Tendon Wrap Tendon Protector, Integra LifeSciences Corporation (2006) Summary page 1.
- K060952: Collagen Nerve Wrap, Collagen Matrix, Inc. (2006) Summary page 1.

## Most influential descendants
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K201572: TAPESTRY Biointegrative Implant (2020), 5 descendants of its own
- K122048: Collagen Tendon Sheet-D (2013), 5 descendants of its own
- K140300: Collagen Tendon Sheet-Ddi (CTS-Ddi) (2014), 4 descendants of its own
- K222501: Regeneten Bioinductive Implant (2023), 3 descendants of its own

## Indications for use
Collagen Tendon Wrap 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/K080452
Methodology: https://510kreport.com/methodology