Product code OQH

Device name

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

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3350

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset