FDA Product Code OQI: Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
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.
Leading manufacturers include Implantcast GmbH.
FDA 510(k) Cleared Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented Devices (Product Code OQI)
About Product Code OQI - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code OQI since 2012, with 5 receiving FDA clearance (average review time: 253 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OQI submissions have been consistent, averaging 263 days recently vs 251 days historically.
OQI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →