Medtech Insight is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

Cortoss goes 510(k) route

This article was originally published in The Gray Sheet

Executive Summary

FDA informs Orthovita that its Cortoss bone augmentation material for vertebroplasty can be reviewed via 510(k) with supporting clinical data rather than through the more burdensome PMA route. Orthovita is nearing completion of enrollment in its randomized pivotal trial comparing Cortoss with polymethylmethacrylate bone cement for osteoporotic vertebral compression fractures. The trial's goal is 255 patients enrolled with at least 162 patients receiving Cortoss with two-year follow-up. The firm plans further discussions with FDA "concerning the length of follow-up data required for the regulatory submission," Orthovita says. The product gained European clearance in January 2003 for screw and vertebral augmentation in VCF...
Advertisement

Related Content

Orthovita Touts Cortoss As Alternative To Cement For Vertebral Fractures
Advertisement
UsernamePublicRestriction

Register

MT024481

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel