FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Biosteon® Screw
K Number: K251680
·
Decision Feb 17, 2026
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
27
Review Days
263
Basic Information
- Device Name
- Biosteon® Screw
- K Number
- K251680
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocomposites, Ltd.
- Date Received
- May 30, 2025
- Decision Date
- February 17, 2026
- Product Code
- MAI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K212721 | Genex Bone Graft Substitute | Feb 4, 2022 | Substantially Equivalent |
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | Jan 23, 2015 | Substantially Equivalent |
| K082381 | GENEX | Nov 14, 2008 | Substantially Equivalent |
| K082383 | FORTOSS VITAL | Sep 5, 2008 | Substantially Equivalent |
| K073341 | GENEX PUTTY | Jul 9, 2008 | Substantially Equivalent |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | Jun 20, 2008 | Substantially Equivalent |
| K072127 | DOMINATOR | Aug 31, 2007 | Substantially Equivalent |
| K071952 | GRAFTLOCK SCREW, ST SCREW | Aug 14, 2007 | Substantially Equivalent |