# K033792: Bilok ST Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Mar 1, 2004 after 87 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 K003641 (2001). 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)
- K011172: Arthrex Bio-Transfix, Arthrex, Inc. (2001) Summary page 1.
- K002070: Biolok Screw, Biocomposites, Ltd. (2000) Summary page 1.
- K021351: Biosteon Cross Pin, Biocomposites, Ltd. (2002) Summary page 1.

## Indications for use
The BiLok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The BiLok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using a double looped (semitendinosus/gracilis) or quadruple (semitendinosus) graft.

Source page: https://510kreport.com/device/K033792
Methodology: https://510kreport.com/methodology