Regeneten Bioinductive Implant
FDA 510(k) K222501 · Smith and Nephew, Inc.
510(k) numberK222501
Submission
- Device name
- Regeneten Bioinductive Implant
- Applicant
- Smith and Nephew, Inc.
Andover, MA, US - Received
- August 18, 2022
- Decision date
- May 11, 2023
- 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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| K251690 | Arthrex SpeedFLEX ImplantOWY · Traditional | Arthrex, Inc. | 09/30/2025SE |
| K252647 | Tapestry Biointegrative ImplantOWY · Special | Embody, Inc. | 09/19/2025SE |
| K250109 | TYBR Collagen GelOWY · Traditional | Tybr Health | 06/06/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | Kerecis Limited | 06/04/2025SE |
| K242631 | REGENETEN Bioinductive ImplantOWY · Traditional | Smith & Nephew Inc., Endoscopy Div. | 11/26/2024SE |
| K220867 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 05/23/2022SE |
| K212306 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 11/02/2021SE |
| 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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| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…GCJ · Traditional | 08/23/2019SE |
| K183232 | Double ENDOBUTTON Fixation DeviceHTN · Traditional | 03/12/2019SE |
| K181746 | MICRORAPTOR Knotless Suture AnchorMAI · Traditional | 09/28/2018SE |
| K180361 | MICRORAPTOR REGENESORB Suture AnchorMAI · Traditional | 05/30/2018SE |
| K163034 | SUTUREFIX Curved Suture AnchorMBI · Traditional | 12/07/2016SE |
Questions and answers
When was Regeneten Bioinductive Implant cleared by the FDA?
Regeneten Bioinductive Implant (K222501) received a 510(k) decision of Substantially Equivalent on May 11, 2023, 266 days after the submission was received.
What is the product code of K222501?
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.