# K251680: Biosteon® Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Feb 17, 2026 after 263 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971358 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202535: Arthrex FastThread Interference Screw, Arthrex, Inc. (2020) Summary page 5.
- K003641: Biolok Screw, Biosteon Screw, Biocomposites, Ltd. (2001) Summary page 5.

## Indications for use
The Biosteon TM Screw is indicated for use in anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), lateral collateral ligament (LCL), and medial patellofemoral ligament (MPFL) reconstruction procedures where the surgeon: • places the graft in tibial and/or femoral tunnels; and • inserts between the tunnel wall and graft to hold the graft in place The Biosteon TM Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL, PCL, MCL, LCL, and MPFL reconstruction. The Bioston TM Screw is used to provide interference fixation during femoral and/or patellar tibial fixation in ACL, PCL, MCL, LCL, and MPFL reconstruction using a soft tissue graft (semi-tendonodesis gracilis).

Source page: https://510kreport.com/device/K251680
Methodology: https://510kreport.com/methodology