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 | 4667 |
| Device Name | Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented |
| Physical State | May Include: Acetabular Shell Acetabular Liner Femoral Head Femoral Stem Femoral Neck Instrumentation |
| Technical Method | A Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis Is A Device Intended To Be Implanted To Replace A Hip Joint. The Two-part Femoral Component Consists Of A Femoral Stem Made Of Alloys To Be Fixed In The In |
| Target Area | Hip |
| Regulation Description | Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous 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 | 888.3353 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4667 |
| Device | Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented |
| Product Code | OQI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis. |
| CFR Regulation Number | 888.3353 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNITED ORTHOPEDIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 12 |
Difficult To Insert | 4 |
Device Dislodged Or Dislocated | 3 |
Appropriate Term/Code Not Available | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
No Apparent Adverse Event | 1 |
Unstable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Device Operates Differently Than Expected | 1 |
Device Slipped | 1 |
Joint | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Unintended Movement | 1 |
| Total Device Problems | 34 |