DeviceClearance

Product code OQI— Orthopedic

CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS

Classification name
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OQI under 21 CFR 888.3353, via openFDA

Market context for product code OQI

FDA has cleared 5 devices under product code OQI between 2012 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OQI

Recent clearances under product code OQI

Data sourced from openFDA. This site is unofficial and independent of the FDA.