# K213018: Auxilock GFS Mini, GFS II Large, and GFS Ultimate

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Nov 18, 2022 after 424 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K792022 (1979). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202259: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip, Parcus Medical, LLC (2020) Summary page 5.

## Indications for use
Auxilock GFS Mini, GFS II Large, GFS Ultimate Mini and GFS Ultimate Large are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Source page: https://510kreport.com/device/K213018
Methodology: https://510kreport.com/methodology