| Device Type ID | 4592 |
| Device Name | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing |
| Regulation Description | Knee Joint Femorotibial 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 One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LGE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4592 |
| Device | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing |
| Product Code | LGE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3530 [🔎] |
| Device Problems | |
|---|---|
Inadequacy Of Device Shape And/or Size | 1 |
Break | 1 |
Insufficient Information | 1 |
Fracture | 1 |
| Total Device Problems | 4 |