Search Results

1. Nonin'lammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheurnatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and throchanteric fractures of the oroximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthoplasty.

All devices are metallic, tapered hip femoral components. Each utlizes a modular ferr oral head component that is taper fit onto the stem at the time of surgery.

The provided document is a 510(k) premarket notification for expanded indications of non-cemented porous coated total hip prostheses. It does not contain information about acceptance criteria, device performance, or any studies using test sets, training sets, or ground truth.

Specifically, the document states under "Clinical and Non-Clinical Testing: None provided." This indicates that no new studies were submitted to support the expanded indications, and the approval is based on substantial equivalence to previously legally marketed devices.

Therefore, I cannot provide the requested information.

Ask a specific question about this device