# K203029: Auxilock Titanium Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Aug 20, 2021 after 322 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 5 generations back to K915424 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083619: Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020, Parcus Medical, LLC (2009) Summary page 5.

## Indications for use
The Auxilock Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Source page: https://510kreport.com/device/K203029
Methodology: https://510kreport.com/methodology