Search Results

Joint replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head.
• rheamatoid arthritis;
• correction of functional deformity;
• formorel fracture
  These devices may also be indicated in the salvage of previously failed surgical attempts.
  Both the Revelation and Linear hip steans are designed for a cementless application.

The modification consists of an additional method of porous coating currently conducted on the hip devices listed above.

This document is a 510(k) premarket notification for a medical device, the Revelation® Hip Stem & Linear Hip Stem. It is not a study demonstrating the device meets acceptance criteria.

The 510(k) process is used to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness and that the device is safe and effective. It explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, this document does not contain the information requested in the prompt, as it is not a study, nor does it list specific acceptance criteria and performance data for this particular device. It mainly focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications, packaging, and sterilization.

To answer your request, a different type of document, such as a study report or a different section of a regulatory submission that includes performance testing results, would be needed.

Ask a specific question about this device