| Device Type ID | 4547 |
| Device Name | Prosthesis, Hip, Semi-constrained, Composite/metal |
| Regulation Description | Hip Joint Metal/composite 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 | 888.3340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KMC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4547 |
| Device | Prosthesis, Hip, Semi-constrained, Composite/metal |
| Product Code | KMC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/composite Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3340 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Noise, Audible | 1 |
Unstable | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zimmer, Inc. | II | Feb-20-2014 |