| K-number | K251680 |
| Device name | Biosteon® Screw |
| Applicant | Biocomposites, Ltd. |
| Product code | MAI |
| Device class | Class II |
| Decision date | Feb 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Biosteon® Screw is a cannulated, tapered, absorbable interference screw made from hydroxyapatite and poly(L-lactide) for use in knee ligament reconstruction procedures (ACL, PCL, MCL, LCL, MPFL). It is inserted between the tunnel wall and graft to provide interference fixation and gradually absorbs into the body.
Compared to the original clearance (K003641), the subject device is tapered and offers a smaller 6mm diameter option. Compared to the primary predicate (Arthrex FastThread, K202535), differences include material composition and design—the subject device is not vented—but these differences do not raise different safety and effectiveness questions.
The document references ISO 13485 for design controls, nonconforming product handling, and corrective/preventative actions. Testing included insertion torque, cyclic pullout displacement, static pullout to failure, and characterization via mass loss and molecular weight analysis at 0, 6, and 12 weeks.
The subject device and predicates share the same intended use and specific indications for knee ligament reconstruction. Technological differences in material composition and design do not raise different questions of safety and effectiveness and are addressed with valid scientific rationale. Performance data from the secondary predicate (K003641) supports sterility, shelf-life, and biocompatibility, with new mechanical testing validating performance for expanded indications.
View the full FDA submission: accessdata.fda.gov