K242302 is an FDA 510(k) clearance for the RejuvaKnee™ Collagen Meniscus Implant. This device is classified as a Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen (Class II - Special Controls, product code OLC).
Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on October 2, 2024, 58 days after receiving the submission on August 5, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. Intended For Use In Surgical Procedures For The Repair And Reinforcement Of Soft Tissue Injuries Of The Medial Meniscus. In Repairing And Reinforcing Medial Meniscal Defects, The Patient Must Have An Intact Meniscal Rim And Anterior And Posterior Horns For Attachment Of The Mesh. In Addition, The Surgically Prepared Site Must Extend At Least Into The Red/white Zone Of The Meniscus To Provide Sufficient Vascularization. The Device Reinforces Soft Tissue And Provides A Resorbable Scaffold That Is Replaced By The Patients Own Soft Tissue. The Device Is Not A Prosthetic Device And Is Not Intended To Replace Normal Body Structure..
| 510(k) Number | K242302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2024 |
| Decision Date | October 02, 2024 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Intended For Use In Surgical Procedures For The Repair And Reinforcement Of Soft Tissue Injuries Of The Medial Meniscus. In Repairing And Reinforcing Medial Meniscal Defects, The Patient Must Have An Intact Meniscal Rim And Anterior And Posterior Horns For Attachment Of The Mesh. In Addition, The Surgically Prepared Site Must Extend At Least Into The Red/white Zone Of The Meniscus To Provide Sufficient Vascularization. The Device Reinforces Soft Tissue And Provides A Resorbable Scaffold That Is Replaced By The Patients Own Soft Tissue. The Device Is Not A Prosthetic Device And Is Not Intended To Replace Normal Body Structure. |