# K033252: Modification to Stryker Bioabsorbable Interference Screw System

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Nov 13, 2003 after 36 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: 2 generations back to K972233 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993166: Stryker Bioabsorbable Interference Screw System, Stryker Endoscopy (2000) Summary page 1.

## Indications for use
The Stryker Bioabsorbable 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 various ACL autografts and allografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.

Source page: https://510kreport.com/device/K033252
Methodology: https://510kreport.com/methodology