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 | 4665 |
| Device Name | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| 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 Has A Femo |
| Target Area | Hip |
| Regulation Description | Hip Joint Metal/polymer/metal Semi-constrained 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3358 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4665 |
| Device | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Product Code | OQG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/polymer/metal Semi-constrained Porous-coated Uncemented Prosthesis. |
| CFR Regulation Number | 888.3358 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENCORE MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ENCORE MEDICAL, L.P. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NOVOSOURCE INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOTAL JOINT ORTHOPEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Insufficient Information | 51 |
Device Dislodged Or Dislocated | 18 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Material Integrity Problem | 13 |
Break | 10 |
Fracture | 7 |
Device Operates Differently Than Expected | 5 |
Material Deformation | 5 |
Difficult To Insert | 4 |
Degraded | 4 |
Mechanical Problem | 3 |
Difficult To Position | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Detachment Of Device Component | 2 |
Thread | 2 |
Loose Or Intermittent Connection | 2 |
Device Difficult To Setup Or Prepare | 2 |
Use Of Device Problem | 2 |
Failure To Adhere Or Bond | 2 |
Unstable | 2 |
Pin | 1 |
Contamination During Use | 1 |
Device Inoperable | 1 |
Osseointegration Problem | 1 |
Physical Resistance | 1 |
Component Missing | 1 |
Deformation Due To Compressive Stress | 1 |
Appropriate Term/Code Not Available | 1 |
Screw | 1 |
Delivered As Unsterile Product | 1 |
Scratched Material | 1 |
Disconnection | 1 |
Device Slipped | 1 |
Device Or Device Fragments Location Unknown | 1 |
Naturally Worn | 1 |
Packaging Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Expulsion | 1 |
| Total Device Problems | 174 |