In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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...

Related Content




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts