# K053339: Allofix Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Mar 16, 2006 after 105 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K904436 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042038: MTF Allograft Anchor, Musculoskeletal Transplant Foundation (2004) Summary page 2.

## Indications for use
The AllofixfM Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.

Source page: https://510kreport.com/device/K053339
Methodology: https://510kreport.com/methodology