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The J-SERIES OMEGA® Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

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The provided text describes a 510(k) premarket notification for the "J-Series Omega Total Hip System II" and its clearance by the FDA in 1999. This document is a regulatory approval letter and an indications for use statement. It does not contain information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications.

The letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

This means the device was cleared based on its substantial equivalence to a predicate device already on the market, rather than on new clinical performance data demonstrating its efficacy or safety against specific acceptance criteria in a dedicated study.

Therefore, I cannot provide the requested information from the given text.

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