# K160364: VersaWrap Tendon Protector

- Pathway: 510(k) (Traditional)
- Applicant: Alafair Biosciences, Inc.
- Decided: Jun 10, 2016 after 122 days
- Product code: OWW (Mesh, Surgical, Absorbable, 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: 2 generations back to K000019 (2000). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 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 4.

## Most influential descendants
- K200311: VersaWrap Tendon Protector (2020), 5 descendants of its own
- K203600: VersaWrap (2021), 4 descendants of its own
- K213163: VersaWrap (2021), 3 descendants of its own
- K240817: VersaWrap (2024), 1 descendant of its own
- K251655: VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (2025), 0 descendants of its own

## Indications for use
The VersaWrap 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/K160364
Methodology: https://510kreport.com/methodology