Search Results

• 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
• 2. Revision of failed femoral head replacements.
• 3. When alternative reconstructive techniques are not viable.
• When arthrodesis is contraindicated. 4.
• 5. Avascular necrosis or fracture of the femoral head.
• 6. Congenital defects that will allow adequate function of the system.

Protract Press-Fit Hip Stem - HA Coated

The provided text is a clearance letter from the FDA for a medical device called the "Protract Press-Fit Hip Stem - HA Coated." It does not contain any information about acceptance criteria, the study design, device performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input document. The document primarily serves as an official communication from the FDA stating that the device has been deemed "substantially equivalent" to predicate devices and can be marketed. It lists the indications for use but does not detail the technical performance or supporting clinical study data.

Ask a specific question about this device