# K061498: Allofix Anchor, 5.0 MM Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Jul 6, 2006 after 36 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904436 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011985: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit, Smith & Nephew, Inc. (2001) Summary page 2.

## Recalls of this device
- May 27, 2015 · Class II · Z-2210-2015: Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.

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

Source page: https://510kreport.com/device/K061498
Methodology: https://510kreport.com/methodology