Medtech Insight 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


Off-Label Concerns With InFuse Raised, But Panel Decides Against Bundling

This article was originally published in The Gray Sheet

Executive Summary

Medtronic/Sofamor Danek successfully avoided a proposed condition that would have bundled its LT-Cage lumbar tapered fusion device with its InFuse bone graft during FDA's Orthopedic & Rehabilitation Devices Panel review Jan. 10

You may also be interested in...

Medtronic InFuse Favored By Study Data, New Payment Code In The Offing

The Centers for Medicare & Medicaid Services should consider a separate ICD-9-CM code for Medtronic's InFuse BMP-2 bone morphogenetic protein pending FDA approval of the device, according to the agency's ICD-9 Coordination and Maintenance Committee

Stryker OP-1 Gains HDE Status For Failed Long-Bone Nonunion Fractures

Stryker plans to begin making its OP-1 (Osteogenic Protein 1) bone morphogenetic protein implant available in the U.S. by year-end under a humanitarian device exemption received from FDA Oct. 17, becoming the first company to have a BMP product reach the U.S. market.

Stryker Will Discuss Rejected OP-1 PMA At Upcoming Meeting With FDA

Stryker expects to meet with FDA by March 1 to discuss the agency's "not approvable" letter for OP-1 bone growth factor for treating nonunion fractures.

Related Content




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