# K003641: Biolok Screw, Biosteon Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Feb 8, 2001 after 73 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 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) Bio Interference Screw (Arthrex): named in the summary without a submission number
- (no number) BioScrew (Livatec): named in the summary without a submission number
- (no number) BioLok® Screw (Biocomposites): named in the summary without a submission number

## Most influential descendants
- K021351: Biosteon Cross Pin (2002), 1 descendant of its own
- K251680: Biosteon® Screw (2026), 0 descendants of its own
- K081390: Bioactif Osteotrans Interfence Screw (2008), 0 descendants of its own
- K050468: Triabsorb Composite Screw (2005), 0 descendants of its own
- K033792: Bilok ST Screw (2004), 0 descendants of its own

## Indications for use
The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon: e places the graft in tibial and/or femoral tunnels; and e inserts screws between the tunnel wall and graft to hold the graft in place. The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

Source page: https://510kreport.com/device/K003641
Methodology: https://510kreport.com/methodology