Definition: 1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proxim
| Device Type ID | 4666 |
| Device Name | Hip, Semi-constrained, Cemented, Metal/polymer + Additive, Cemented |
| Physical State | May Include: Acetabular Shell Acetabular Liner Femoral Head Femoral Stem Femoral Neck Instrumentation |
| Technical Method | This Device Is Intended To Be Implanted To Replace A Hip Joint. The Device Limits Translation And Rotation In One Or More Planes Via The Geometry Of Its Articulating Surfaces. It Has No Linkage Across-the-joint. This Generic Type Of Device Includes P |
| Target Area | Hip |
| Regulation Description | Hip Joint 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4666 |
| Device | Hip, Semi-constrained, Cemented, Metal/polymer + Additive, Cemented |
| Product Code | OQH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3350 [🔎] |