# K993166: Stryker Bioabsorbable Interference Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Aug 4, 2000 after 317 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
Longest line of descent: 1 generation back to K972233 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 1.
- K972233: Stryker Wedge Interference Screw System, Stryker Endoscopy (1997) Summary page 2.

## Most influential descendants
- K033252: Modification to Stryker Bioabsorbable Interference Screw System (2003), 0 descendants of its own

## Recalls of this device
- Dec 27, 2004 · Not classified · Z-0401-05: The label on the outside of the shipping box has an incorrect description of the screw diameter.

## Indications for use
Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranous tendon graft, and the Achilles tendon graft.

Source page: https://510kreport.com/device/K993166
Methodology: https://510kreport.com/methodology