BioBrace® Extra-Articular Ligament Augmentation Kit
FDA 510(k) K252946 · Conmed Corporation
510(k) numberK252946
Submission
- Device name
- BioBrace® Extra-Articular Ligament Augmentation Kit
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- September 15, 2025
- Decision date
- October 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
| 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 |
|---|---|---|
| K261363 | Y-Knotless Flex AnchorsMBI · Special | 05/13/2026SE |
| K253763 | Y-Knotless Flex AnchorsMBI · Special | 01/29/2026SE |
| K251530 | CONMED Argo Knotless® AnchorMBI · Special | 06/18/2025SE |
| K250395 | BioBrace ® RC Delivery SystemORQ · Traditional | 04/07/2025SE |
| K244025 | Argo Knotless GENESYS AnchorMBI · Special | 01/28/2025SE |
| K242187 | BioBrace®OWW · Traditional | 11/27/2024SE |
| K240127 | PlumeSafe X5 Smoke Management SystemFYD · Traditional | 08/05/2024SE |
| K241906 | BioBrace® Reinforced ImplantOWW · Special | 07/29/2024SE |
| K240090 | Argo Knotless GENESYS AnchorMAI · Traditional | 03/05/2024SE |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer MarylandGEI · Traditional | 10/23/2023SE |
Questions and answers
When was BioBrace® Extra-Articular Ligament Augmentation Kit cleared by the FDA?
BioBrace® Extra-Articular Ligament Augmentation Kit (K252946) received a 510(k) decision of Substantially Equivalent on October 15, 2025, 30 days after the submission was received.
What is the product code of K252946?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.