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    Breaking News

    Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System

    The Consortium-designed circular external fixator can treat complex foot/ankle deformities and provide a static frame for various indications.

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    EINPresswire09.30.20
    Carbon22, a GLW Inc. company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FusionFrame Ring Lock System, a circular external fixator. This system was designed to be simple-to-use with a wide range of assembly components. FusionFrame was developed in part in collaboration with the Carbon22 Consortium, a select group of orthopedic and podiatric surgeons.
     
    The design ensures circumferential access for precise fixation and can address a variety of indications in a straightforward and cost-effective manner. Multi-level constructs may be built to target the zone of pathology or apex of a deformity.
     
    Axel Cremer, chief technology officer for Carbon22, stated, “The 510(k) clearance for our FusionFrame Ring Lock System is an exciting milestone for Carbon22. Our team has done an excellent job of expanding our circular external fixator technology platform and building on the clinical success of the existing Ring Lock System. We’re excited to launch the FusionFrame Ring Lock System and look forward to introducing future variations which are currently in development.”
     
    The FusionFrame Ring Lock System represents next-level functionality, utilizes state-of-the-art materials, and boasts an unparalleled design that provides the ability to customize frames specific to patient needs. This system can treat complex foot and ankle deformities, as well as provide a static frame for various indications.
     
    “As we continue to develop our new, patent-pending technology platforms, designed to allow for visualization of fusion sites (intraoperatively) and post-operative healing zones, we are working to ensure that foot and ankle surgeons have the right devices they needto treat today’s foot and ankle conditions,“ said Thomas H. Lee M.D., chief medical officer for Carbon22.
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    Smith+Nephew Launches NOVOSTITCH PRO Meniscal Repair System in Europe Smith+Nephew Launches NOVOSTITCH PRO Meniscal Repair System in Europe
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      PR Newswire 01.19.21

    • OrthoPediatrics Expands Agent Network in Three European Countries

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    • Spine/Neurology
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      Data demonstrate the device’s respect for neural anatomy and conformability to bony endplates through Adaptive Geometry.
      Globe Newswire 01.18.21


    • Large Joint
      Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA

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      Study shows that an enhanced recovery program leads to optimal results after knee replacement surgery.
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    • Spine/Neurology
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    • New Chief Clinical Officer on Board at IncludeHealth

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    • Imaging
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      Siemens Healthineers 01.14.21

    • CMS Expedites Breakthrough Device Access; Industry Applauds

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    • Biologics
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      ViBone Moldable is the newest orthobiologics solution of Surgalign’s bone graft portfolio to support spinal fusion.
      GlobeNewswire 01.13.21


    • Orthopedic Surgical Robots Market to Exceed $4.1 Billion by 2029

      Orthopedic Surgical Robots Market to Exceed $4.1 Billion by 2029

      Surgical robots associated with advantages such as better visualization of the operating field and lessened tremor.
      Persistence Market Research 01.13.21

    • ARCH Global Precision Acquires LISI Medical Jeropa Inc.

      ARCH Global Precision Acquires LISI Medical Jeropa Inc.

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      ARCH Global Precision 01.12.21

    • Large Joint
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    • Extremities
      FDA Clears Nvision Biomedical

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      Nvision Biomedical Technologies 01.12.21

    • Avalign Technologies Acquires Slice Manufacturing Studios

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    Breaking News
    • DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution
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    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Making the Grade: Orthopedic Materials Spotlight
    • Mending Mishaps: A Trauma Technology Overview
    • Life, Interrupted: The 2020 Year in Review
    • View More >

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