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

What Is It?

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.

What Is FDA Product Code OQH?

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented is FDA product code OQH, Class 2, 21 CFR 888.3350.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.