BioBrace®
FDA 510(k) K242187 · Conmed Corporation
510(k) numberK242187
Submission
- Device name
- BioBrace®
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- July 25, 2024
- Decision date
- November 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWW – Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Other 510(k)s with product code OWW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)OWW · Traditional | Alafair Biosciences | 07/18/2025SE |
| K250021 | RotiumOWW · Traditional | Nanofiber Solutions, LLC | 02/27/2025SE |
| K241906 | BioBrace® Reinforced ImplantOWW · Special | Conmed Corporation | 07/29/2024SE |
| K240817 | VersaWrapOWW · Traditional | Alafair Biosciences, Inc. | 06/14/2024SE |
| K222220 | SpinMedix Absorbable Fibrous MembraneOWW · Traditional | Celestray Biotech Company, LLC., | 07/06/2023SE |
| K230316 | FlexBand; FlexPatch; FlexBand PlusOWW · Traditional | International Life Sciences | 05/26/2023SE |
| K203267 | The BioBrace ImplantOWW · Traditional | Biorez, Inc. | 04/30/2021SE |
| K160364 | VersaWrap Tendon ProtectorOWW · Traditional | Alafair Biosciences, Inc. | 06/10/2016SE |
| K121216 | STR GraftOWW · Traditional | Soft Tissue Regeneration, Inc. | 11/21/2012SE |
More from Soft Tissue Regeneration, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261363 | Y-Knotless Flex AnchorsMBI · Special | 05/13/2026SE |
| K253763 | Y-Knotless Flex AnchorsMBI · Special | 01/29/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | 10/15/2025SE |
| 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 |
| 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® cleared by the FDA?
BioBrace® (K242187) received a 510(k) decision of Substantially Equivalent on November 27, 2024, 125 days after the submission was received.
What is the product code of K242187?
The FDA product code is OWW – Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.