OQI

5 FDA 510(k) clearances · Product code

FDA profile

Official device name

Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3353

Medical specialty

Orthopedic

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2015: 9 · 2016: 17 · 2023: 23 · 2024: 35 · 2025: 45 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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