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

What Is This Device?

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.

How Is OQI Classified?

Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented is FDA product code OQI, Class 2, 21 CFR 888.3353.

What Does It Take to Sell It in the United States?

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.

What Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2022. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2) and Packaging change control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.