OSSIOfiber® Interference Screw
FDA 510(k) K252022 · OSSIO , Ltd.
510(k) numberK252022
Submission
- Device name
- OSSIOfiber® Interference Screw
- Applicant
- OSSIO , Ltd.
Caesarea, IL - Received
- June 30, 2025
- Decision date
- August 19, 2025
- 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 |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| 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 |
|---|---|---|
| K254077 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | 05/01/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | 02/24/2026SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | 05/27/2025SE |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional | 04/03/2025SE |
| K241932 | OSSIOfiber® Compression StapleMNU · Traditional | 08/28/2024SE |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | 07/03/2024SE |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation NailsHWC · Traditional | 03/08/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | 12/01/2023SE |
| K233302 | OSSIOfiber® Compression StapleMNU · Traditional | 11/16/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | 09/13/2023SE |
Questions and answers
When was OSSIOfiber® Interference Screw cleared by the FDA?
OSSIOfiber® Interference Screw (K252022) received a 510(k) decision of Substantially Equivalent on August 19, 2025, 50 days after the submission was received.
What is the product code of K252022?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.