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

FDA expands indication for Titan Spine's Endoskeleton

This article was originally published in Clinica

Executive Summary

The US FDA has expanded the labelling of Titan Spine's Endoskeleton to include its use as an interbody fusion device. Its previous 510(k) clearance in September 2003 covered its use for vertebral body replacement. Mequon, Wisconsin-based Titan explained that the device was previously used to replace bone, but can now also replace spinal discs. The new indication is for skeletally-mature patients with degenerative disc disease at one or two contiguous levels from the second lumbar to the first sacral vertebra, who have already received six months of non-operative treatment. Titan hopes the expanded indication will increase adoption of the product, and estimates that 65 million people in the US have some type of degenerative disc condition.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT040887

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