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The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

The S-ROM Zirconia Ceramic femoral head is manufactured of either Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR® or ZYRANOX™ zirconia ceramic. The S-ROM ceramic femoral head is designed to be used with 11/13 Morse-taper femoral stems composed of either titanium alloy or cobalt-chromium alloy.

This document, K980081, is a 510(k) premarket notification for the S-ROM Zirconia Ceramic Femoral Head. It is not a study report that describes acceptance criteria and device performance based on a study. Instead, it is a submission to the FDA demonstrating substantial equivalence to a predicate device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from this document.

The document states:

• "The S-ROM Zirconia Ceramic Femoral Head is identical in design (drawing specifications) to the S-ROM Zirconia Ceramic Femoral Head cleared for marketing under premarket notification K973307 (November 20, 1997) for use with titanium alloy femoral components."
• "The S-ROM Zirconia Ceramic Femoral Head is identical in material (PROZYR® or ZYRANOX™) to the S-ROM Zirconia Ceramic Femoral Head cleared for marketing under premarket notifications K973307 and K921111."
• "The subject device is to be utilized with the same 11/13 Morse-taper femoral components as the predicate device mentioned above (S-ROM Zirconia Ceramic Femoral Head). The difference between the femoral stems which will be utilized is the material composition of either titanium or cobalt-chromium alloy."

This indicates that the manufacturer is asserting equivalence based on design and material similarity to previously cleared devices, rather than presenting a new study with specific acceptance criteria and performance data for this particular submission. The FDA's letter confirms substantial equivalence without requiring a new clinical performance study.

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