Biosteon® Screw
FDA 510(k) K251680 · Biocomposites, Ltd.
510(k) numberK251680
Submission
- Device name
- Biosteon® Screw
- Applicant
- Biocomposites, Ltd.
Keele, GB - Received
- May 30, 2025
- Decision date
- February 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional | OSSIO , Ltd. | 04/03/2025SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | 06/12/2025SE |
| K250521 | NanoBone® SBX Putty ; NanoBone® QDMQV · Traditional | 04/07/2025SE |
| K212721 | Genex Bone Graft SubstituteMQV · Traditional | 02/04/2022SE |
| K141830 | Stimulan Kit, Stimulan Rapid CureMQV · Traditional | 01/23/2015SE |
| K082381 | GenexMQV · Traditional | 11/14/2008SE |
| K082383 | Fortoss VitalLYC · Special | 09/05/2008SE |
| K073341 | Genex PuttyMQV · Traditional | 07/09/2008SE |
| K081428 | Modification to Doubleplay Suture AnchorHWC · Special | 06/20/2008SE |
| K072127 | DominatorHWC · Special | 08/31/2007SE |
| K071952 | Graftlock Screw, ST ScrewHWC · Special | 08/14/2007SE |
Questions and answers
When was Biosteon® Screw cleared by the FDA?
Biosteon® Screw (K251680) received a 510(k) decision of Substantially Equivalent on February 17, 2026, 263 days after the submission was received.
What is the product code of K251680?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.