# K972233: Stryker Wedge Interference Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Aug 5, 1997 after 50 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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 no predicate by number.

## Most influential descendants
- K993166: Stryker Bioabsorbable Interference Screw System (2000), 1 descendant of its own
- K033252: Modification to Stryker Bioabsorbable Interference Screw System (2003), 0 descendants of its own
- K020097: Stryker Interference Screw Cross Pin System (2002), 0 descendants of its own
- K012270: Stryker Cross-Pinned  Interference Screw System (2001), 0 descendants of its own

## Recalls of this device
- Nov 17, 2017 · Class II · Z-0837-2018: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

## Indications for use
The Stryker Wedge Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the femoral and tibial bony attachments of the patelia bone-patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon graits, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts.

Source page: https://510kreport.com/device/K972233
Methodology: https://510kreport.com/methodology