# K193451: Titanium Interference Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 24, 2020 after 73 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: 1 generation back to K934469 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934469: Arthrotek Interference Screw, Biomet, Inc. (1994) Summary page 4.

## Indications for use
Titanium Interference Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

Source page: https://510kreport.com/device/K193451
Methodology: https://510kreport.com/methodology