| Device Type ID | 4541 |
| Device Name | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Regulation Description | Wrist Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JWJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4541 |
| Device | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Product Code | JWJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Wrist Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFE SCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 46 |
Adverse Event Without Identified Device Or Use Problem | 24 |
Migration Or Expulsion Of Device | 18 |
Inadequacy Of Device Shape And/or Size | 6 |
Protective Measures Problem | 4 |
Naturally Worn | 3 |
Material Erosion | 3 |
Failure To Adhere Or Bond | 3 |
Unstable | 3 |
Compatibility Problem | 3 |
Appropriate Term/Code Not Available | 3 |
Delamination | 2 |
Patient-Device Incompatibility | 2 |
Fracture | 1 |
Device Dislodged Or Dislocated | 1 |
Degraded | 1 |
Metal Shedding Debris | 1 |
Delivered As Unsterile Product | 1 |
Device Contamination With Biological Material | 1 |
| Total Device Problems | 126 |