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The OMEGA "HA" Coated 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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This document is a 510(k) clearance letter from the FDA for the OMEGA® HA Coated Total Hip System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance from a study, or details about such a study.

The letter explicitly states:
"You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation, only)."

This indicates that the FDA's decision was based on demonstrating equivalence, not on specific performance metrics or clinical study results that would typically be described with acceptance criteria. The clearance seems to be based on the composition and design, assuming similar performance to existing conventional porous coated hip prostheses.

Therefore, I cannot provide the requested information from the provided text as it is not present in the document.

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