SuturePatch Tissue Reinforcement
FDA 510(k) K243480 · Arthrex, Inc.
510(k) numberK243480
Submission
- Device name
- SuturePatch Tissue Reinforcement
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- November 8, 2024
- Decision date
- May 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWX – Mesh, Surgical, Non-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 in tendon repair.
Other 510(k)s with product code OWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitOWX · Special | ZuriMED Technologies AG | 01/02/2026SE |
| K250997 | Integrity ImplantOWX · Traditional | Anika Therapeutics, Inc. | 06/17/2025SE |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…OWX · Traditional | ZuriMED Technologies AG | 12/11/2024SE |
| K223538 | Integrity ImplantOWX · Traditional | Anika Therapeutics, Inc. | 08/17/2023SE |
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| 510(k) | Device | Decision |
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| K262451 | Arthrex DynaNite StaplesJDR · Traditional | 09/01/2026SE |
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| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
Questions and answers
When was SuturePatch Tissue Reinforcement cleared by the FDA?
SuturePatch Tissue Reinforcement (K243480) received a 510(k) decision of Substantially Equivalent on May 29, 2025, 202 days after the submission was received.
What is the product code of K243480?
The FDA product code is OWX – Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.