Definition: Call For PMAs To Be Filed By 1/3/05 Per 69 FR 59134 On 10/4/04 - Intended To Replace The Articulating Surfaces Of The Hip While Preserving The Femoral Head And Neck And Indicated For Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Avascula
| Device Type ID | 4656 |
| Device Name | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/polymer, Uncemented |
| Physical State | This Generic Type Of Device Includes Prostheses That Consist Of A Femoral Cap Component Made Of A Metal Alloy, Such As Cobalt-chromium-molybdenum, Or A Ceramic Material, That Is Placed Over A Surgically Prepared Femoral Head, And An Acetabular Resurf |
| Technical Method | 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. |
| Target Area | Hip Joint |
| Regulation Description | Hip Joint Metal/polymer Or Ceramic/polymer Semiconstrained Resurfacing 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 | PMA |
| CFR Regulation Number | 888.3410 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OCG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4656 |
| Device | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/polymer, Uncemented |
| Product Code | OCG |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Hip Joint Metal/polymer Or Ceramic/polymer Semiconstrained Resurfacing Cemented Prosthesis. |
| CFR Regulation Number | 888.3410 [🔎] |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 1 |