# K961234: Depuy Advantage Fixation Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jun 19, 1996 after 82 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
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy M. Kurosaka™ Interference Screw: named in the summary without a submission number
- (no number) DePuy M. Kurosaka™ Fixation Screw: named in the summary without a submission number
- (no number) Arthrex Transtibial™ System: named in the summary without a submission number

## Most influential descendants
- K981670: Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw (1998), 18 descendants of its own
- K982662: Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw (1998), 17 descendants of its own
- K993073: Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 (1999), 16 descendants of its own
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), 15 descendants of its own
- K052080: Matryx Interference Screw (2005), 13 descendants of its own

## Indications for use
The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.

Source page: https://510kreport.com/device/K961234
Methodology: https://510kreport.com/methodology