Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
The Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented (product code OQH) is an orthopedic hip prosthesis intended for total hip arthroplasty in patients with conditions such as osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity, or femoral fractures unmanageable by other means. It is also indicated for revision procedures when prior devices or treatments have failed. As an FDA Class 2 device under regulation 888.3350, premarket clearance via 510(k) is required. The device is flagged as an implant within the Orthopedic specialty. It is not life-sustaining.
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Basic Information
- Product Code
- OQH
- Device Class
- FDA class 2
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.