VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
FDA 510(k) K251655 · Alafair Biosciences
510(k) numberK251655
Submission
- Device name
- VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
- Applicant
- Alafair Biosciences
Austin, TX, US - Received
- May 30, 2025
- Decision date
- July 18, 2025
- 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 |
|---|---|---|---|
| K250021 | RotiumOWW · Traditional | Nanofiber Solutions, LLC | 02/27/2025SE |
| K242187 | BioBrace®OWW · Traditional | Conmed Corporation | 11/27/2024SE |
| 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 |
|---|---|---|
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional | 07/22/2025SE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional | 07/17/2025SE |
| K240817 | VersaWrapOWW · Traditional | 06/14/2024SE |
| K232029 | VersaWrap Nerve ProtectorJXI · Traditional | 11/02/2023SE |
| K213163 | VersaWrapFTM · Special | 10/29/2021SE |
| K203600 | VersaWrapFTM · Traditional | 03/09/2021SE |
| K201631 | VersaWrap Nerve ProtectorJXI · Traditional | 09/14/2020SE |
| K200311 | VersaWrap Tendon ProtectorFTM · Special | 03/06/2020SE |
| K160364 | VersaWrap Tendon ProtectorOWW · Traditional | 06/10/2016SE |
Questions and answers
When was VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) cleared by the FDA?
VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (K251655) received a 510(k) decision of Substantially Equivalent on July 18, 2025, 49 days after the submission was received.
What is the product code of K251655?
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.