Arthrex SpeedFLEX Implant
FDA 510(k) K251690 · Arthrex, Inc.
510(k) numberK251690
Submission
- Device name
- Arthrex SpeedFLEX Implant
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- June 2, 2025
- Decision date
- September 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWY – Mesh, Surgical, Collagen, 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.
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| K220867 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 05/23/2022SE |
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| K201572 | TAPESTRY Biointegrative ImplantOWY · Traditional | Embody, Inc. | 10/19/2020SE |
| K151083 | BioBridge Collagen MatrixOWY · Traditional | Fibralign Corporation | 01/08/2016SE |
| K140300 | Collagen Tendon Sheet-Ddi (Cts-Ddi)OWY · Traditional | Rotation Medical, Inc. | 03/26/2014SE |
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Questions and answers
When was Arthrex SpeedFLEX Implant cleared by the FDA?
Arthrex SpeedFLEX Implant (K251690) received a 510(k) decision of Substantially Equivalent on September 30, 2025, 120 days after the submission was received.
What is the product code of K251690?
The FDA product code is OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.