OQH

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

Product code

OQH

Device name

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

Device class

Class 2

21 CFR

21 CFR 888.3350

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).