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    Breaking News

    FDA Clears CoreLink's M3 Stand-Alone ALIF System

    M3 Stand-Alone Anterior Lumbar (ALIF) System. Images courtesy of Business Wire.
    M3 Stand-Alone Anterior Lumbar (ALIF) System. Images courtesy of Business Wire.
    Related CONTENT
    • FDA Clears Orthofix's G-Beam Fusion Beaming System
    • NuVasive Launches ALIF Retractor Platform for Lateral and Supine Approaches
    • CoreLink Launches Foundation 3D Printed Titanium Interbody Cages
    • Spineology Reveals 12-Month Outcomes for Interbody Fusion Clinical Trial
    • CoreLink Names Vice President of Research and Development
    Business Wire09.13.18
    CoreLink Surgical, LLC, achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the M3 Stand-Alone Anterior Lumbar (ALIF) System.
     
    Jay Bartling, CEO, said, "M3 is our first stand-alone interbody fusion device to feature 3D printing—I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products.”
     
    The M3 system is a sterile packed, 3-screw, integrated fixation device for ALIF procedures, featuring a universal bi-directional design with a simple and intuitive locking mechanism. M3 was also developed utilizing CoreLink’s proprietary Mimetic Metal technology and features unique patent pending StrutSure technology, which creates a combination of load-sharing support structure and interconnected lattice minimizing material density for imaging.
     
    With this new clearance, the CoreLink 3D printed ALIF portfolio, both Foundation 3D ALIF and M3 ALIF, feature the largest footprint size available on the market, allowing for additional options to accommodate an ideal anatomical fit. “I’m always in pursuit of sizing cages to capture as much of the cortical ring that borders the endplates as possible. A larger cage option allows me a more appropriate fit for some patients. Additionally, a larger cage can be helpful for greater surface contact with the endplates, which can enhance stability for a higher likelihood for fusion,” said Neurosurgeon, Justin L. Owen, M.D., FAANS (Slidell, LA).
     
    “Our R&D team concentrated on creating a product that would feature our additive manufacturing capabilities, while also streamlining procedural efficiency. We’re extremely proud of the unique universal instruments offered with M3,” said David Castleman, VP of research and development for CoreLink.
     
    CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where a full display of the Foundation 3D Products will be featured.
    Related Searches
    • development
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    FDA OKs Renovis Surgical FDA OKs Renovis Surgical's Trabecular Hyperlordotic ALIF Interbody Spinal Fusion System
    FDA OKs Spineology FDA OKs Spineology's Rampart One Standard ALIF Device for Stand-Alone Use
    CoreLink Acquires Israeli Firm Expanding Orthopedics Inc. CoreLink Acquires Israeli Firm Expanding Orthopedics Inc.
    FDA OKs Camber Spine FDA OKs Camber Spine's ENZA-A 3D Printed Titanium ALIF System
    Spinal Elements Initiates Expanded Release of Its Clutch Interspinous Process Device Spinal Elements Initiates Expanded Release of Its Clutch Interspinous Process Device
    CoreLink Names Vice President of Research and Development CoreLink Names Vice President of Research and Development
    Spineology Reveals 12-Month Outcomes for Interbody Fusion Clinical Trial Spineology Reveals 12-Month Outcomes for Interbody Fusion Clinical Trial
    CoreLink Launches Foundation 3D Printed Titanium Interbody Cages CoreLink Launches Foundation 3D Printed Titanium Interbody Cages
    NuVasive Launches ALIF Retractor Platform for Lateral and Supine Approaches NuVasive Launches ALIF Retractor Platform for Lateral and Supine Approaches
    FDA Clears Orthofix FDA Clears Orthofix's G-Beam Fusion Beaming System

    Related Breaking News

    • Spine/Neurology
      Nevro Files U.S. Patent Lawsuit Against Stimwave

      Nevro Files U.S. Patent Lawsuit Against Stimwave

      Nevro asserts Stimwave is infringing patent's covering the Senza system and HF10 therapy.
      PR Newswire 02.15.19

    • Large Joint
      Global Study Finds High Success Rate for Hip and Knee Replacements

      Global Study Finds High Success Rate for Hip and Knee Replacements

      Findings showed eight out of ten total knee replacements and six out of ten total hip replacements will still be in place after 25 years.
      University of Bristol 02.15.19

    • Spine/Neurology
      Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study

      Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study

      SIMPACT is a cannulated and fenestrated screw, intended for sacroiliac joint fusion.
      Business Wire 02.15.19


    • MIS/Robotics
      McGinley Orthopedics Recruits Industry Leader as New CEO

      McGinley Orthopedics Recruits Industry Leader as New CEO

      Carl O'Connell most recently served as CEO of Xtant Medical.
      PR Newswire 02.14.19

    • Spine/Neurology
      Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion

      Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion

      Trial conducted by Inspired Spine.
      PR Newswire 02.14.19

    • Tegra Medical Names New GM

      Tegra Medical Names New GM

      Hal Blenkhorn promoted to general manager of Franklin location.
      Tegra Medical 02.13.19


    • Integra Launches the Panta 2 TTC Arthrodesis Nail System

      Integra Launches the Panta 2 TTC Arthrodesis Nail System

      The product is designed to achieve bone healing through appropriate bone fixation and bone compression.
      Globe Newswire 02.13.19

    • 3-D Printing/Additive Mfg. | Spine/Neurology
      PrinterPrezz & SI Bone Team Up to Advance 3D Printed Orthopedic Tech

      PrinterPrezz & SI Bone Team Up to Advance 3D Printed Orthopedic Tech

      PrinterPrezz will provide SI-BONE with development and build services for potential future 3D-printed advanced medical devices and implants.
      Business Wire 02.12.19

    • Zimmer Biomet Appoints Senior Vice President, Chief Human Resources Officer

      Zimmer Biomet Appoints Senior Vice President, Chief Human Resources Officer

      Company recruited new executive from Pfizer.
      Zimmer Biomet Holdings Inc. 02.12.19


    • Spine/Neurology
      Alphatec Provides Update on NuVasive Patent Lawsuit

      Alphatec Provides Update on NuVasive Patent Lawsuit

      Several favorable developments were announced regarding the company's ongoing patent litigation.
      GlobeNewswire 02.11.19

    • Bracing/Prosthetics
      Motorized Brace to Help Children with Cerebral Palsy

      Motorized Brace to Help Children with Cerebral Palsy

      Research team receives start-up funding to develop first-of-its-kind "artificial muscle."
      University of Delaware 02.11.19

    • Spine/Neurology
      FDA Approves Orthofix

      FDA Approves Orthofix's M6-C Artificial Cervical Disc for Cervical Disc Degeneration Treatment

      The disc was developed by Spinal Kinetics, a company Orthofix acquired last spring.
      Business Wire 02.11.19

    • American Academy of Orthopaedic Surgeons Announces its Musculoskeletal Tumor Registry Pilot

      American Academy of Orthopaedic Surgeons Announces its Musculoskeletal Tumor Registry Pilot

      Year-long effort includes six pilot sites at major U.S. academic center.
      American Academy of Orthopaedic Surgeons 02.08.19

    •  Trice Medical Acquires SegWAY Orthopaedics

      Trice Medical Acquires SegWAY Orthopaedics

      Acquisition creates first company to offer product line for minimally invasive orthopedic diagnostics and surgical solutions.
      Business Wire 02.07.19

    • Gramercy Extremity Orthopedics Receives Patent for Variable Angle Locking Technology

      Gramercy Extremity Orthopedics Receives Patent for Variable Angle Locking Technology

      The patent covers a design that allows a screw to be fixed at various angles and orientations using self-aligning washers within the plate hole.
      EINPresswire.com 02.07.19


    Breaking News
    • Nevro Files U.S. Patent Lawsuit Against Stimwave
    • Global Study Finds High Success Rate for Hip and Knee Replacements
    • Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study
    • McGinley Orthopedics Recruits Industry Leader as New CEO
    • Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion
    View Breaking News >
    CURRENT ISSUE

    January/February 2019

    • The 11 Steps of Metrology Matching
    • Realizing the Promise of Pre-Validated Packaging
    • Creating a Natural Extension: Instrument Manufacturing
    • Squeaky Clean: Orthopedic Device Packaging & Sterilization
    • Natural Selection: Biologics in Orthopedics
    • View More >

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