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The Nelson Resurfacing Head is indicated for use in:

• a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• b.) rheumatoid arthritis

The Nelson Resurfaced Heads are intended for cemented application and for single use implantation.

This device is design to save the natural femur and provide a new surface on the femoral head for the hip to pivot on. The natural acetabulum will remain intact. The device will be manufactured out of cobalt-chrome-molybdenum. This device is intended for use with those who have had significant osteonecrosis of the femoral head. This procedure is limited to treating the diseased portion of the joint without violating the femoral canal with the stem of prosthesis.

This document (K983452) is a 510(k) premarket notification decision letter from the FDA. It does not include a study that proves the device meets acceptance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically involve detailed clinical studies proving performance against specific acceptance criteria in the way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information from this document because it is not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on presenting novel clinical study results with acceptance criteria.

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