| Device Type ID | 4466 |
| Device Name | Prosthesis, Knee, Hemi-, Femoral |
| Regulation Description | Knee Joint Femoral (hemi-knee) Metallic Uncemented 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 | 888.3570 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | HSA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4466 |
| Device | Prosthesis, Knee, Hemi-, Femoral |
| Product Code | HSA |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Knee Joint Femoral (hemi-knee) Metallic Uncemented Prosthesis. |
| CFR Regulation Number | 888.3570 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 5 |
Failure To Adhere Or Bond | 5 |
Break | 3 |
Loose Or Intermittent Connection | 2 |
Appropriate Term/Code Not Available | 2 |
Disassembly | 1 |
| Total Device Problems | 18 |