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    Breaking News

    FDA Clears OrthoPediatrics' Small Stature Scoliosis System with 26th Surgical System

    The system represents the company’s 26th surgical system and is expected to launch in the fourth quarter of 2018.

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    • FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    • First Surgery Performed with OrthoPediatrics' Pediatric Nailing Platform | FEMUR
    GlobeNewswire10.19.18
    OrthoPediatrics Corp., a company exclusively focused on advancing the field of pediatric orthopedics, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis.  The system represents the company’s 26th surgical system and is expected to launch in the fourth quarter of 2018.
     
    The RESPONSE 4.5/5.0mm System was designed in collaboration with pediatric orthopedic surgeons focused on additional solutions for treating complex pediatric scoliosis patients. It expands the company’s RESPONSE platform to treat smaller stature children and builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System. The RESPONSE 4.5/5.0mm System offers a hybrid implant technology allowing the option of either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome material, multiple implant connector options, and innovative, new instrumentation.
     
    OrthoPediatrics’ executive vice president, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our 4.5/5.0mm system, which allows physicians to better treat smaller statures and patients at a younger age. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring their innovative vision to life with another surgical solution for treating complex pediatric scoliosis.  The addition of the new system to our scoliosis platform continues to demonstrate OrthoPediatrics’ focus and commitment to providing solutions for children with complex spinal disorders.”
     
    Scott Luhmann, M.D., Chief of Staff at Shriners Hospital for Children-St. Louis and Associate Professor in the Department of Orthopedic Surgery and Fellowship Director of Pediatric Orthopedic Surgery at Washington University School of Medicine, commented, “The new Response 4.5/5.0mm System brings OrthoPediatrics’ expertise and passion for musculoskeletal care of pediatric patients to the area of spinal deformity. This surgeon-centric system is focused on surgical efficacy and efficiency with an elegant rod reduction tool that significantly cuts down laborious task time in the effort to provide optimal patient outcome.”
    Related Searches
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    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
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    Related Breaking News

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      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.
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    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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