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

Medical Tubing and Extrusion

Medical tubing and extrusion technologies

  • Technologies
    • Balloons
    • Brain-computer interfaces
    • Cardiac Implants
    • Catheters
    • Endoscopes
    • Heart valves
    • Pulsed Field Ablation
  • Components
    • Connectors
    • Needles and Injections
    • Seals
    • Tubing Components
  • Manufacturing
    • Coatings
    • Extrusions
    • Machining
    • Molding
      • Injection Molding
      • Insert molding
      • Mold Components
    • Tools
  • Materials
    • Advanced Materials
    • Metals
    • Nitinol
    • Plastics
    • Silicone
  • Business
    • Distribution Agreements
    • Legal News
    • Mergers & Acquisitions
    • Partnerships
    • Personnel Moves
  • Regulatory
    • 510(k)
    • CE Mark
    • FDA Breakthrough Designation
    • ISO Certification
    • Pre-Market Approval (PMA)
    • Recalls
  • Suppliers
  • About Us

FDA clears Stryker biodegradable subacromial balloon spacer

July 14, 2021 By Danielle Kirsh

Stryker InSpace expandable balloonStryker (NYSE:SYK) this week announced that it received FDA de novo clearance for its balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears.

Kalamazoo, Mich.–based Stryker designed the InSpace balloon implant to restore the subacromial space without requiring sutures or fixation devices. The device has demonstrated improved shoulder motion and function, according to the company.

“Current strategies treating massive irreparable rotator cuff tears often present a challenge to surgeons and may require long and frustrating rehabilitation processes for patients,” Dr. Nikhil Verma, the lead investigator in the clinical study, said in a news release. “The results of the study demonstrate the InSpace balloon is a ‘game-changer’ and presents a shorter, less invasive option that may enable sustained, clinically meaningful improvements in shoulder function and symptoms.”

Stryker acquired the arthroscopic treatment balloon implant from OrthoSpace in 2019. It has a successful clinical history of over 10 years and 29,000 balloons implanted outside of the U.S. and the level I study conducted across North America.

“We are extremely excited about the clearance of InSpace because it provides a new surgical option for surgeons to address their unmet MIRCT needs in the shoulder continuum of care,” Matt Moreau, Stryker’s sports medicine vice president and general manager, said. “We are committed to the advancement of shoulder arthroscopy, and InSpace offers a unique opportunity for us to better partner with our customers on their clinical objectives to improve patient outcomes around a very challenging pathology in the shoulder.”

Filed Under: Balloons Tagged With: stryker

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

Primary Sidebar

“mte
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest trends and developments in medical tubing and extrusion.
MDO ad

Sponsored Content

A new way to access scientific papers?

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website

MEDTECH 100 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.

Footer

Inv Logo

MASSDEVICE MEDICAL NETWORK

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

Medical Tubing + Extrusion

Subscribe to our E-Newsletter
Advertise with us
About
Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

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 | RSS