Biosteon® Screw— 510(k) K251680
Substantially EquivalentBiocomposites, Ltd.
FDA 510(k) clearance K251680 for Biosteon® Screw, Substantially Equivalent on 2026-02-17. Applicant: Biocomposites, Ltd.. Device class: 2.
Summary
Biocomposites' Biosteon® Screw is filed under product code MAI, biodegradable soft tissue fixation fastener. The record doesn't describe the screw beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Biocomposites filed from Keele, United Kingdom. The decision came 263 calendar days after FDA received it (May 30, 2025 to February 17, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Biocomposites, Ltd.
- Product code
- Product code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keele, GB
Recent devices under product code MAI
view allMore clearances from Biocomposites, Ltd.
view allAdverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.