Tendon Protect (50242)
FDA 510(k) K243843 · Kerecis Limited
510(k) numberK243843
Submission
- Device name
- Tendon Protect (50242)
- Applicant
- Kerecis Limited
Isafjordur, IS - Received
- December 13, 2024
- Decision date
- June 4, 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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| K242631 | REGENETEN Bioinductive ImplantOWY · Traditional | Smith & Nephew Inc., Endoscopy Div. | 11/26/2024SE |
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| 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 |
More from Rotation Medical, Inc.
| 510(k) | Device | Decision |
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| K251844 | Kerecis SurgiBind (50241)OXH · Special | 07/15/2025SE |
| K241080 | Kerecis Parvus (50207)KGN · Traditional | 08/21/2024SE |
| K213904 | Kerecis OralNPL · Traditional | 09/30/2022SE |
| K213231 | Kerecis SiliconeKGN · Traditional | 06/29/2022SE |
| K202430 | Kerecis ReconstructOXH · Traditional | 05/02/2021SE |
| K192612 | Kerecis Gingiva GraftNPL · Traditional | 11/13/2020SE |
| K190528 | MariGen Wound ExtraKGN · Traditional | 07/10/2019SE |
| K153364 | Kerecis SecureMeshOXE · Traditional | 08/19/2016SE |
| K132343 | Marigen Wound DressingKGN · Traditional | 10/23/2013SE |
Questions and answers
When was Tendon Protect (50242) cleared by the FDA?
Tendon Protect (50242) (K243843) received a 510(k) decision of Substantially Equivalent on June 4, 2025, 173 days after the submission was received.
What is the product code of K243843?
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.