Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
The Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement of Tendon is an absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists during tendon repair procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWW, with regulation number 878.3300, reviewed under the orthopedic panel within the General, Plastic Surgery specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OWW
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Jul 18, 2025 | Substantially Equivalent | Alafair Biosciences |
| K250021 | Rotium | Feb 27, 2025 | Substantially Equivalent | Nanofiber Solutions, LLC |
| K242187 | BioBrace® | Nov 27, 2024 | Substantially Equivalent | Conmed Corporation |
| K241906 | BioBrace® Reinforced Implant | Jul 29, 2024 | Substantially Equivalent | Conmed Corporation |
| K240817 | VersaWrap | Jun 14, 2024 | Substantially Equivalent | Alafair Biosciences, Inc. |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Jul 06, 2023 | Substantially Equivalent | Celestray Biotech Company, LLC., |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | May 26, 2023 | Substantially Equivalent | International Life Sciences |
| K203267 | The BioBrace Implant | Apr 30, 2021 | Substantially Equivalent | Biorez, Inc. |
| K160364 | VersaWrap Tendon Protector | Jun 10, 2016 | Substantially Equivalent | Alafair Biosciences, Inc. |
| K121216 | STR GRAFT | Nov 21, 2012 | Substantially Equivalent | Soft Tissue Regeneration, Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.