| Device Type ID | 4620 |
| Device Name | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/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 | 888.3560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MBV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4620 |
| Device | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer |
| Product Code | MBV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3560 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 7 |
Migration Or Expulsion Of Device | 6 |
Fracture | 3 |
Misassembled | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Naturally Worn | 2 |
Packaging Problem | 2 |
Material Erosion | 2 |
Device Packaging Compromised | 2 |
Loss Of Or Failure To Bond | 1 |
Failure To Adhere Or Bond | 1 |
Compatibility Problem | 1 |
| Total Device Problems | 31 |