• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to footer
  • MANUFACTURERS
  • HEADHUNTERS
  • PRODUCT SECTIONS
  • COMPANIES

SPINEMarketGroup

Spine Industry News

  • HOME
  • 2025
  • 2024
  • BROCHURES
  • ARTICLES
  • VIDEOS

Safe Orthopaedics receives 510k approval from the FDA for the sale of its 2nd Generation of SteriSpineTM PS in the United States

August 10, 2020 By SPINEMarketGroup

Eragny-sur-Oise, France, August 10th à 6.00 PM CEST – Safe Orthopaedics (FR0013467123 – ALSAF), a company specializing in the design and marketing of ready-to-use technologies for spinal surgeries, delivering the safest treatment of spinal fractures urgently treated, is annoucing today the 510k approval from the American Regulatory Agency Food and Drug Administration (FDA), for the sale its 2nd Generation of SteriSpineTM PS in the United States.

Developed in 2010, SteriSpineTM PS is the first technology of pedicle screws combined to a ready-to-use instrumentation (single use and sterile) worldwide. As more than ten thousand surgeries have been performed, Safe orthopaedics has been announcing in 2019 the launch of its 2ndgeneration. Significantly thinner, more rigid and still radiolucent, SteriSpineTM PS 2nd generation enables the surgeon to perform the surgery in an even more mini-invasive approach, and can be used on a wider number of spine pathologies.

Safe Orthopaedics has been enhancing business development of SteriSpineTMPS 2nd generation since  the beginning of 2020. In the first quarter, technology was delivered to Japan, and in the second quarter, it was available to several Europeans countries and in Asia Pacific area. At the end of the year, all direct French, English and German direct customers will have been converted.

Following this 510k approval from the FDA, Safe Orthopaedics is getting ready for its commercial launch.

« Obtaining the FDA approval for the 2nd Generation SteriSpineTMPS in the United States is an important milestone in entering our second decade, as we observe a real adoption of ready-to-use technologies on a global scale and growing competition. Thanks to the feedback from our European users, we have designed this thinner, more rigid and totally radio-lucent evolution for an easier minimally invasive surgery, now meeting the expectations of American surgeons.», comments Pierre Dumouchel, Safe Orthopaedics Chief Executive Officer. « Following our first experience in the United States, we are very attentive to developments happening in the world’s leading market, and are organizing ourselves to make the SteriSpineTMPS second generation available to American surgeons. The acceleration of outpatient surgeries, in dedicated centers called Ambulatory Surgery Centers (ASC), represents a new business opportunity for Safe Orthopedics. Combined with a very short production cycle made possible by the acquisition of LCI Medical, in 2021 we will launch a new distribution method, totally digital and perfectly fitted to the ASC. “

Finally, Safe Orthopedics, which already holds around a hundred patents, is also announcing today the acquisition of the Japanese patent for its Oak screw, an implant from the SteriSpineTMPS range offering an unprecedented minimally invasive surgical technique for treating high-energy fractures.

About Safe Orthopaedics 
Founded in 2010, Safe Orthopaedics is a French medical technology company, a pioneer of the design and marketing of innovative ready-to-use technologies (single-use implants and instruments) for spinal diseases, delivering the safest treatment of spinal fractures. The technologies include sterile implants and ready-to-use instruments available to the surgeon at any time and anywhere, enabling minimally invasive approaches, reducing the risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpineTM Kits are CE marked, FDA and CFDA approved. 
Safe Orthopaedics, has its headquarters close to Paris (95610 Eragny-Sur-Oise – France) and has created sales subsidiaries in the UK, Germany and in the US, and since July 2020 has industrial subsidiaries in France and Tunisia.
Safe Orthopaedics is employing around 150 employes and delivers its products worldwide.


For more information : www.SafeOrthopaedics.com   


Contacts 

Safe Orthopaedics                                                                                                                 
François-Henri Reynaud                                                     
Chief Financial Officer                        
Tél. : +33 (0)1 34 21 50 00                                               
[email protected]                   

Press relations
Ulysse Communication
Bruno Arabian / +33 (0)6 87 88 47 26 / [email protected]
Nicolas Daniels / +33 (0)6 63 66 59 22 / [email protected]

(Visited 34 times, 7 visits today)

Filed Under: NEWS Tagged With: 2020, NEWS

Primary Sidebar

PLATINUM SPONSORS

GOLD SPONSORS

MOST POPULAR POSTS

  • BROCHURES
  • Just Reflective, Not Disappointed: Globus Medical’s…
  • What’s Happening with Globus Medical? Why Has the…
  • (UPDATED 2025): 6 Artificial Cervical Discs You’ll…
  • (UPDATED 2024): +8 Lumbar Artificial Discs to Know…
  • Stryker’s Spine Business Sale: A Smart Move or a…
  • Globus Medical to Execute $500 Million Share Buyback…
  • Globus Medical extends versatility of Advanced…
  • Eminent Spine’s 3D Printed Titanium Pedicle Screw…
  • Dispute Over Spinal Implant Royalties Between…
  • M6 Discontinued: What Are the Alternatives for a…
  • The Crown Is Still Medtronic’s… For Now!
  • Orthofix Discontinues M6-C™ and M6-L™ Artificial…
  • Alphatec Today: Where It Stands and Where It’s Heading?
  • (Updated!) 15 Expandable PLIF Cages to Know…!
  • (UPDATED 2024): +108 Stand-Alone Cervical Cages to Know..!
  • Stryker’s Spine Exit: What It Means for…
  • Why Didn’t Globus Medical’s Stock Rise After…
  • Globus Medical Reports First Quarter 2025 Results
  • Viscogliosi Brothers Completes Acquisition of U.S.…
  • LAST 10 VIDEOS PUBLISHED

    1. Biedermann Motech: MOSS 100 (Short)
    2. POWEHI MEDICAL AG: KUDOS™ Modular
    3. POWEHI MEDICAL AG: TANTO® Screw
    4. Syntropiq: Taurus TLIF (Short)
    5. LEM Surgical: Dynamis Surgical Robot
    6. Aegis Spine:PathLoc-TA
    7. NGMedical: MOVE®-C Artificial Disc
    8. B.Braun Aesculap: Ennovate® Cervical MIS
    9. Spineart: PERLA® TL Deformity Solutions
    10. NGMedical: MOVE®-C

    Recent Comments

    • Peter on A New Player in Spinal Care, POWEHI Medical!
    • Sandy on Just Reflective, Not Disappointed: Globus Medical’s Bittersweet Q1 2025
    • SPINEMarketGroup on M6 Discontinued: What Are the Alternatives for a Cervical Artificial Disc?
    • Sergio López-Fombona on M6 Discontinued: What Are the Alternatives for a Cervical Artificial Disc?
    • Drew on Has Globus Already Surpassed Medtronic in the Spine Market? Can J&J Find Its Way Back to the Top?
    • Ahmed Hassan El-Naggary on Has Globus Already Surpassed Medtronic in the Spine Market? Can J&J Find Its Way Back to the Top?
    • Email
    • Twitter
    • YouTube

    Subscribe to Our Newsletter!

    Check your inbox or spam folder to confirm your subscription.

    Footer

    • Email
    • Twitter
    • YouTube

    Contact us:

    [email protected] [email protected]

    PRIVATE POLICY

    • Legal Advice
    • Embed Link
    • VIDEOS

    Copyright © 2025 · SPINEMarketGroup

    Manage Cookie Consent
    To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
    Functional Always active
    The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
    Preferences
    The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
    Statistics
    The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
    Marketing
    The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
    Manage options Manage services Manage {vendor_count} vendors Read more about these purposes
    View preferences
    {title} {title} {title}