# K031937: Alantech Graft Fixation Screw

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Sep 4, 2003 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: 3 generations back to K915424 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992945: Rci Fixation Screws (with Assorted Sizes), Smith & Nephew, Inc. (1999) Summary page 1.
- K915424: Arthrex Cannulated Interference Screw, Arthrex, Inc. (1993) Summary page 1.

## Indications for use
The Atlantech Graft Fixation Screw is an interference screw for use in the fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery.

Source page: https://510kreport.com/device/K031937
Methodology: https://510kreport.com/methodology