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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A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
