Definition: Call For PMAs To Be Filed By 12/26/96 Per 61 FR 50710 On 9/27/96
| Device Type ID | 4552 |
| Device Name | Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/metal |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/metal/metal 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 One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | PMA |
| CFR Regulation Number | 888.3550 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KRP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4552 |
| Device | Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/metal |
| Product Code | KRP |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/metal/metal Constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3550 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 2 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 3 |