Definition: Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Sur
| Device Type ID | 4643 |
| Device Name | Prosthesis, Knee, Femorotibial, Semi-constrained, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer |
| Regulation Description | Knee Joint Femorotibial (uni-compartmental) Metal/polymer Porous-coated 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 | 510(k) |
| CFR Regulation Number | 888.3535 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NJD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4643 |
| Device | Prosthesis, Knee, Femorotibial, Semi-constrained, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer |
| Product Code | NJD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Femorotibial (uni-compartmental) Metal/polymer Porous-coated Uncemented Prosthesis. |
| CFR Regulation Number | 888.3535 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MAKO SURGICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |