OQI — Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class II
FDA product code OQI covers "Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented", a Class II medical device regulated under 21 CFR 888.3353. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OQI
- Device Class
- Class II
- Regulation Number
- 888.3353
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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 proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252451 | implantcast | EPORE® XO cup system | April 24, 2026 |
| K192989 | maxx orthopedics | Libertas E-XLPE Modular Liner | October 29, 2020 |
| K172833 | united orthopedic corporation | E-XPE Acetabular Components and U-Motion II Acetabular Cup | June 12, 2018 |
| K173583 | exactech | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | March 12, 2018 |
| K111481 | corin usa | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS | February 6, 2012 |