Definition: The Device Is A Metatarsophalangeal Joint Cartilage Replacement Device That Is Implanted In The Metatarsal Head Of The First Metatarsophalangeal Joint.
| Device Type ID | 4755 |
| Device Name | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Physical State | The Device Is A Molded Cylindrical Viscoelastic Hydrogel Implant Composed Of Polyvinyl Alcohol And Saline. |
| Technical Method | The Device Is Placed Into The Metatarsal Head In The First MTP Joint Via Press-fit Implantation. The Viscoelastic Hydrogel Form And Properties Of The Device Are Conducive To Replacing Focal Areas Of Damaged Cartilage, Providing Pain Reduction, And Ma |
| Target Area | The Device Is Implanted Into The Metatarsal Head In The First MTP Joint. |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PNW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4755 |
| Device | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Product Code | PNW |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
Material Fragmentation | 3 |
Insufficient Information | 1 |
Fracture | 1 |
| Total Device Problems | 16 |