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    Breaking News

    FDA Clears Life Spine's SI Joint Revision Offering

    Additional claims for the SImpact Sacroiliac Joint Fixation System were also cleared.

    Related CONTENT
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    Business Wire09.23.20
    Life Spine, a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, has received clearance from the U.S. Food & Drug Administration (FDA) to market a SI revision offering and additional claims for the SImpact Sacroiliac Joint Fixation System.
     
    The new clearance adds a 14.5mm diameter screw to Life Spine’s SI fixation portfolio. The new size focuses on filling a missing gap in the market for revision surgeries. The larger screw joins the current offering of self-drilling 12mm and 8mm diameter threaded implants.
     
    "As sacroiliac fusions become more mainstream, revision surgeries are increasing due to failures of early devices and poor surgical technique,” said Dr. Ali Mesiwala of the Southern California Center for Neuroscience and Spine. “Currently revision strategies for a non-union or malpositioned implant involve removal of the prior implant, placement of new instrumentation, and addition of bone graft. A particularly challenging problem with these cases is how best to fill the void of bone that is left when the old implant is removed. The large diameter of the SImpact Revision implant allows one to fill the bone void while supplying immediate fixation to the site. This unique implant will self-harvest local bone and can be pre-packed and post-packed with allograft to aid in fusion, making SImpact the go-to system for any SI fusion revision."
     
    Additional claims, indications, and length offerings have also been granted to the SImpact system. The implant is self-harvesting and can be used prophylactically in long construct cases. All implants in the system are now offered in overall lengths of 30mm – 110mm in 5mm increments. Lastly, the 8mm diameter lag screws now include the aggressive self-drilling screw tip geometry that allows for minimized surgical steps.
     
    “The SImpact system is already a robust offering for SI fixation. The additions of the revision screw, updated lag screw, and the new indications are great adjuncts to the portfolio,” said Dr. Keith Maxwell of Southeastern Sports Medicine and Orthopedics. “The system provides an innovative answer to long construct spinopelvic fixation and having implant lengths up to 110mm makes it an ideal system to be used in trauma cases. I have performed numerous SI fixation procedures with many different implants and SImpact is the most appealing system on the market.”
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      PR Newswire 01.19.21

    • OrthoPediatrics Expands Agent Network in Three European Countries

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      Broadened its reach into the largest European market of Germany, Austria, and Switzerland.
      GlobeNewswire 01.18.21

    • Spine/Neurology
      Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes

      Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes

      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

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

      Study shows that an enhanced recovery program leads to optimal results after knee replacement surgery.
      American Academy of Orthopaedic Surgeons 01.15.21

    • Spine/Neurology
      Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.

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      Full-body MRI conditional devices combine therapy options for personalized pain relief.
      PR Newswire 01.15.21

    • New Chief Clinical Officer on Board at IncludeHealth

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      New hire is a double board certified orthopedic and sports therapist.
      IncludeHealth 01.14.21


    • Imaging
      Cios Flow from Siemen Healthineers Cleared by FDA

      Cios Flow from Siemen Healthineers Cleared by FDA

      Enables easier, more efficient operation to improve patient care in the OR.
      Siemens Healthineers 01.14.21

    • CMS Expedites Breakthrough Device Access; Industry Applauds

      CMS Expedites Breakthrough Device Access; Industry Applauds

      New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’
      ODT Staff 01.13.21

    • Biologics
      Surgalign Launches New Device for Bone Formation

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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.

      Broadens the portfolio of products and end markets served by ARCH.
      ARCH Global Precision 01.12.21

    • Large Joint
      Rice U. Computational Model Offers Help for New Hips

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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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      Adds Slice’s additive manufacturing, high tolerance subtractive manufacturing, and sterile packaging capabilities.
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    • Biologics
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    Trending
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    Breaking News
    • DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution
    • OrthoPediatrics Expands Agent Network in Three European Countries
    • Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes
    • Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    • Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    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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