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 Hor
| Device Type ID | 4703 |
| Device Name | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen |
| Physical State | The Device Is Provided In One Configuration: A Semi-lunar Shape With A Triangular Cross-section For Use In The Medial Meniscus. The Device Is A Resorbable Collagen Matrix Composed Primarily Of Bovine Type I Collagen (~99%) Derived From Achilles Tendo |
| Technical Method | The Device Is A Partially Resorbable Scaffold Intended For The Repair And Reinforcement Of Soft Tissue Injuries Of The Medial Meniscus. For Proper Implantation Of The Device, A Partial Meniscectomy Is Performed And Necessary Tissue Is Removed To Expo |
| Target Area | Medial Meniscus |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4703 |
| Device | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen |
| Product Code | OLC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Corporation | II | Mar-12-2018 |