# K053655: Tendon Wrap Tendon Protector

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Feb 3, 2006 after 35 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: 1 generation back to K000019 (2000). 2 ancestors in all.
39 later devices descend from it; 7 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041620: Neura Wrap Nerve Protector, Integra Lifesciences Corp. (2004) Summary page 1.
- K000019: Single Size Tendon Spacer, Medist International (2000) Summary page 1.

## Most influential descendants
- K080452: Collagen Tendon Wrap (2008), 15 descendants of its own
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K061473: Surgi-Wrap Mast Bioresorbable Sheet (2006), 13 descendants of its own
- K063648: Surgi-Wrap Mast Tendon Sheet (2007), 12 descendants of its own
- K072190: Ortho-Wrap Bioresorbable Sheet (2008), 10 descendants of its own

## Indications for use
Tendon Wrap™ Tendon Protector 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/K053655
Methodology: https://510kreport.com/methodology