• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA clears Tornier’s Simpliciti shoulder repair device

FDA clears Tornier’s Simpliciti shoulder repair device

March 10, 2015 By Brad Perriello

FDA clears Tornier's Simpliciti shoulder repair device

Tornier (NSDQ:TRNX) today said the FDA cleared its new Simpliciti shoulder repair device for patients whose osteoarthritis or traumatic arthritis resulted in severely painful and/or disabled shoulder joints.

Amsterdam-based Tornier, which is gearing up for a $3.3 billion merger-of-equals with Wright Medical (NSDQ:WMGI), said the safety watchdog based its 510(k) clearance on a 3-year investigational device exemption trial of the Simpliciti device.

"In my practice, a new category of younger, more active patients has emerged. These patients are more demanding and aren’t satisfied with modifying their lifestyle as a result of shoulder pain. The humeral canal-sparing design and revision optionality of the Simpliciti shoulder system allows me to address this patient population that I have been hesitant to treat with traditional implant systems," lead investigator Dr. Sean Churchill said in prepared remarks. "Another benefit of the ultra-short stem design is the absence of a metal implant extending into the distal humeral canal, thereby reducing the risk of a mid-shaft humerus fracture, which can serve to compromise typical total shoulder implants."

"We are very pleased with the results of the Simpliciti clinical study which supported the FDA’s swift clearance of this innovative product. Studies, such as the Simpliciti IDE, serve as a testament to Tornier’s ongoing commitment to responsible science and technological evolution that provides extremity surgeons and their patients with unique solutions to address the debilitating results of osteoarthritis," added Tornier president & CEO Dave Mowry. "Similar to our market-leading Aequalis Ascend Flex shoulder system, we plan to introduce the Simpliciti product through a measured process to ensure education and training paces our product deployment. We believe building long-term success in this new category will take an investment in training and education while allowing the market time to develop."

The Tornier-Wright merger is awaiting the approval of U.S. anti-trust regulators, who last month extended their review of the deal with a formal request for more information.

Filed Under: Food & Drug Administration (FDA), News Well, Orthopedics, Regulatory/Compliance Tagged With: Shoulders, Tornier Inc.

More recent news

  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure
  • Ambu wins FDA clearance for first single-use cysto-nephroscope
  • Tandem Diabetes Care pairs t:slim X2 pump with Abbott FreeStyle Libre 3 Plus in U.S.
  • Ypsomed, CamDiab to integrate Abbott dual glucose-ketone sensor into automated insulin delivery system

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy