Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Stryker Sets Trident Ceramic Hip Launch, Frets OP-1 Delay

This article was originally published in The Gray Sheet

Executive Summary

Stryker is planning a U.S. launch of the Trident ceramic-on-ceramic hip prosthesis in the second half of the year, the company says following receipt of an approvable letter from FDA.

You may also be interested in...



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 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.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT014788

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

Cancel