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This article was originally published in The Gray Sheet

Executive Summary

Orthopedic devices manufacturer is preparing 510(k) submissions for two constrained hip products, the ZCA "All-Poly" acetabular cup and Trilogy acetabular system constrained liner, following the recent downclassification of constrained hip liners from Class III to Class II (1"The Gray Sheet" May 6, 2002, p. 19). Announced by FDA April 30 and effective May 30, the final rule reclassifying of hip joint metal/polymer constrained cemented or uncemented prostheses has the effect of "potentially shortening the product review and approval cycle from years to months," Zimmer notes...

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