• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10 Orthopedic Device Firms
    • Buyers' Guide
    • Events
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10 Orthopedic Device Firms
  • Buyers' Guide
  • Events
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    Top Features
    From Nitinol to Nanotubes: A Materials Science Roundtable

    In Good Repair: Trauma Technologies Under Review

    Anxious Undertones: A Review of 2019

    Automated Analysis Advantages for Part Validation

    Tried and True Metalworking
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    Orthofix Appoints New Spine Business Leader

    Viant to Halt EtO Sterilization at Michigan Plant by End of Year

    Synaptive Medical's Modus V Expands Into Spine Market

    3D-Printed Graftless Bone Transplants Go to Clinical Trials

    CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    3D-Printed Graftless Bone Transplants Go to Clinical Trials

    CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

    Micro Spine Implant Could Restore Standing and Walking

    RTI Surgical Appoints New Division Leaders

    From Nitinol to Nanotubes: A Materials Science Roundtable
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    Molybdenum-Rhenium Biomaterial: Something ‘MoRe’?

    New Exoskeleton Shoulders Rehab Burden for Stroke Patients

    Repairing Knee Cartilage Defects with the Patient's Own Cells

    Compamed 2019 Preview Report

    Straightening Out a Spinal Device’s De Novo Pathway
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Five Star Manufacturing Inc.

    NN Life Sciences

    Donatelle

    Orchid Orthopedic Solutions

    Orthopedic Innovation Pty. Ltd.
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10 Orthopedic Device Firms
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Breaking News

    FDA Clears Medacta's Midline Cortical Pedicle Screw Placement Guide

    MySpine MC technique avoids interference with the cranial facet joints and accommodates larger screw diameters and lengths.

    FDA Clears Medacta
    MySpine is a patient specific pedicle screw placement guide, allowing the surgeon to determine pre-operative 3D planning based on CT images of the patient’s spine. Image courtesy of Medacta.
    Related CONTENT
    • FDA Clears Medicrea's 3D-Printed Titanium Interbody Devices
    • FDA Clears Chemence Medical's Exofin Fusion Skin Closure System
    • FDA Clears Anika Therapeutics' Injectable HA-Based Bone Repair Treatment
    • FDA Clears IlluminOss Medical's Bone Stabilization System
    • FDA Clears Centric Medical's Cannulated Screw Internal Fixation System
    Business Wire05.23.18
    Medacta International, the family-owned global leader in innovative joint replacement and spinal technologies, announced clearance from the U.S. Food and Drug Administration (FDA) and the addition of MySpine Midline Cortical Pedicle Screw Placement Guide (MySpine MC) to its MySpine portfolio. The first two stateside surgeries utilizing MySpine MC were conducted this month, first by Nima Salari, M.D., of Scottsdale Shea Medical Center in Scottsdale, Ariz., followed by Jeffrey Henn, M.D., of Lee Memorial Hospital in Fort Myers, Fla.
     
    MySpine MC enables surgeons to optimize procedures for both outpatient and inpatient settings and foster more rapid patient recovery through an accurate and reliable muscle-sparing approach to posterior lumbar surgery. This new technology guides the screw to a trajectory in the pedicle that evolved from the well-established cortical bone trajectory (CBT). Through accurate CT-based preoperative planning of a more caudomedial entry point than traditional pedicle screw trajectories and a less extreme caudal-cranial angle than CBT, the MySpine MC technique avoids interference with the cranial facet joints and accommodates larger screw diameters and lengths, with four points of cortical bone purchase for enhanced biomechanical fixation.
     
    Achieving this improved screw trajectory through a small midline incision with a patient-matched guide can bring speed and reliability to the operating room, while potentially accelerating patient recovery and decreasing the risk of pedicle fractures, facet joint violation and nerve root injury. The intraoperative utilization of 3D-printed guides for pedicle screw placement facilitates accurate replication of pre-surgical planning to achieve the fine-tuned screw trajectory and may further reduce radiation exposure, muscular dissection and operative time.
     
    Dr. Salari’s patient, the first to undergo surgery with MySpine MC, had dynamic spondylolisthesis at the L4/L5 level with severe spinal stenosis and neurogenic claudication, complicated by a history of diabetes and cardiovascular disease. “Given my patient’s condition and history,” Dr. Salari said, “I needed a minimally invasive option that would allow for a wide central decompression reinforced by excellent stabilization. We also needed to minimize anesthesia time for the patient, so it needed to be quick. The ability to pre-plan the surgery and work with a product that had been fully customized for the patient proved incredibly valuable. The surgery was fast, the screw placement was accurate, and the fixation was reliable. To top it off, we were able to reduce the need for intra-operative fluoroscopy, limiting the patient’s radiation exposure.”
     
    Dr. Henn’s patient, who had severe stenosis and spondylolisthesis, is an athlete who was looking for the least invasive surgical solution. His goal was a relatively rapid return to his training and racing. Regarding the surgery, Dr. Henn said: “My patient’s pathology required decompression and instrumented fusion, historically a significant surgery with a long recovery. Using Medacta’s MySpine technology, prior to the procedure I was able to perform detailed surgical planning based on his specific anatomy. The result was a highly successful surgery, which I was able to perform in minimal time through a small incision. The MySpine guides worked flawlessly and, as a result, the need for intraoperative radiation was minimized, which was better for the patient and for the surgical team. The patient did very well and within one day of surgery, was walking extensively and reported less pain than he had prior to surgery—clearly a benefit of using the MySpine MC minimally invasive technique. I was extremely pleased with the system, and my patient was even more so.”
     
    First introduced in 2014, Medacta’s MySpine technology can be customized for each patient’s anatomy and surgeon’s preferences and has been associated with greater accuracy of pedicle screw positioning, compared to freehand and other techniques, as well as reduced radiation, operative time and hospital stay. MySpine MC expands upon those benefits by enabling a biomechanically superior screw trajectory achieved through a minimally invasive approach. Surgeons across Europe, Australia and Asia have utilized MySpine MC and this novel multi-cortical approach in more than 100 spinal surgeries to date. MySpine MC is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, providing continuous educational and developmental support to Medacta surgeons as they work towards discovering new technologies and supporting patients.
     
    “Medacta is known for disrupting surgical techniques with technology-backed approaches that are both surgeon- and patient-friendly,” said Francesco Siccardi, Executive Vice President of Medacta International. “Minimally invasive cortical bone fixation makes sense for posterior lumbar surgeries, but the technology to optimize and support it was lacking for many years. MySpine MC provides the answer to that need for the benefit of patients and surgeons alike.”
    Related Searches
    • facet joint
    • 3d-printed
    • cardiovascular
    • medacta international
    Suggested For You
    Modifications to a Cleared Device: Letter to File or New 510(k)? Modifications to a Cleared Device: Letter to File or New 510(k)?
    Shouldering Growth: An Examination of the Extremities Implant Sector Shouldering Growth: An Examination of the Extremities Implant Sector
    CrossRoads Extremity Systems Launches Active Stabilization MPJ Implant System CrossRoads Extremity Systems Launches Active Stabilization MPJ Implant System
    FDA Clears Ceterix Orthopaedics FDA Clears Ceterix Orthopaedics' NovoStitch Pro Meniscal Repair System
    First Implantation of Spinal Resources First Implantation of Spinal Resources' Swedge Pedicle Screw System
    FDA Clears Orthofix FDA Clears Orthofix's G-Beam Fusion Beaming System
    Medical Device Quality: Why Software Is More Challenging Than Hardware Medical Device Quality: Why Software Is More Challenging Than Hardware
    Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for TLIF Surgery Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for TLIF Surgery
    FDA Clears Exactech FDA Clears Exactech's Equinoxe Stemless Shoulder
    AAOS: Medacta Launches Medial Partial Knee and Shoulder System AAOS: Medacta Launches Medial Partial Knee and Shoulder System
    Why the FDA-Approved Blood Test Is Not About Concussions Why the FDA-Approved Blood Test Is Not About Concussions
    Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant
    FDA Clears First Blood Test to Help Evaluate Concussion in Adults FDA Clears First Blood Test to Help Evaluate Concussion in Adults
    FDA Clears Multi Radiance Medical Super Pulsed Lasers for Neck and Shoulder Pain FDA Clears Multi Radiance Medical Super Pulsed Lasers for Neck and Shoulder Pain
    FDA Clears UC Davis Startup FDA Clears UC Davis Startup's Polymer to Aid Bone Regrowth

    Related Breaking News

    • Spine/Neurology
      Orthofix Appoints New Spine Business Leader

      Orthofix Appoints New Spine Business Leader

      Kevin Kenny was previously VP of U.S. sales for Spine and Biologics at Medtronic.
      Business Wire 12.05.19

    • Packaging & Sterilization
      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.
      Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19

    • Spine/Neurology
      Synaptive Medical

      Synaptive Medical's Modus V Expands Into Spine Market

      Modus V’s robotic arm moves automatically based on the positions of tracked surgical instruments.
      Business Wire 12.04.19


    • 3-D Printing/Additive Mfg. | Biologics | Materials
      3D-Printed Graftless Bone Transplants Go to Clinical Trials

      3D-Printed Graftless Bone Transplants Go to Clinical Trials

      ADAM is piloting the use of ceramics and polymer in 3D-printed bone implants, able to be produced at commodity prices.
      PR Newswire 12.04.19

    • Extremities
      CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

      CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

      The add-on acquisition furthers CrossRoads' strategy to build a market-leading company in the high-growth orthopedic extremities sector.
      PR Newswire 12.04.19

    • Spine/Neurology
      Micro Spine Implant Could Restore Standing and Walking

      Micro Spine Implant Could Restore Standing and Walking

      Hair-like electrical wires send electrical signals to trigger networks that already know how to do the hard work.
      University of Alberta Faculty of Medicine & Dentistry 12.03.19


    • Spine/Neurology
      RTI Surgical Appoints New Division Leaders

      RTI Surgical Appoints New Division Leaders

      Terry Rich, experienced spine leader, named president, Global Spine; Olivier Visa elevated to president, Global OEM.
      GlobeNewswire 12.03.19

    • KCI Introduces Solution for Challenging Surgical Locations

      KCI Introduces Solution for Challenging Surgical Locations

      Company's latest technology targets post-operative incisions and surrounding soft tissue.
      Business Wire 12.03.19

    • EOS Imaging Receives FDA 510(k) Clearance for Next-Gen Imaging System

      EOS Imaging Receives FDA 510(k) Clearance for Next-Gen Imaging System

      EOSedge will be unveiled at the RSNA Annual Meeting.
      Business Wire 12.02.19


    • Large Joint
      mediCAD is Now Officially a Medical Device in Japan

      mediCAD is Now Officially a Medical Device in Japan

      The product is an orthopedic planning solution for hip, knee, shoulder, hand, leg, or spine surgery.
      mediCAD Hectec GmbH 12.02.19

    • Imaging
      New Generation Imaging System Launched in Europe and Canada

      New Generation Imaging System Launched in Europe and Canada

      EOS Imaging will unveil its EOSedge at the upcoming Radiological Society of North America (RSNA) 2019 Annual Meeting.
      Business Wire 11.26.19

    • Software & Quality
      Survey Identifies Challenges to Improving Product Development Processes

      Survey Identifies Challenges to Improving Product Development Processes

      81% of medical device companies are not using tools designed for the medical device industry in their quality management processes.
      PRWeb 11.26.19

    • Extremities
      Arthrosurface Introduces the SpiralUp TCL Allograft System

      Arthrosurface Introduces the SpiralUp TCL Allograft System

      Joint-preserving allograft addresses ankle instability and benefits the entire musculoskeletal system.
      Arthrosurface Inc. 11.26.19

    •  Exactech Acquires Italian Distributor

      Exactech Acquires Italian Distributor

      The deal gives Exactech direct operations in eight global markets with distribution in more than 35 countries.
      Businesswire 11.25.19

    • Spine/Neurology
      FDA Clears Expanded Multi-Level Use of NuVasive

      FDA Clears Expanded Multi-Level Use of NuVasive's CoRoent Small Interlock System

      The product is an anterior cervical interbody fusion system for use in adult patients with cervical disc degeneration and/or cervical spinal instability.
      PR Newswire 11.22.19


    Breaking News
    • Orthofix Appoints New Spine Business Leader
    • Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    • Synaptive Medical's Modus V Expands Into Spine Market
    • 3D-Printed Graftless Bone Transplants Go to Clinical Trials
    • CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • From Nitinol to Nanotubes: A Materials Science Roundtable
    • In Good Repair: Trauma Technologies Under Review
    • Anxious Undertones: A Review of 2019
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    Cristo Rey High School Educator Named 2019 Axalta All-Pro Teacher of the Year
    Michelman Makes United Way of Greater Cincinnati’s List of Top 25 Corporate Campaigns
    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Roche's Nasal Swab MRSA Test
    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Awarded $1M BMGF Grant
    Vivera Pharma, Parexel Ink Clinical Services Agreement
    MedPharm Triples Capacity at RTP Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WWP Wins Three NJPEC Awards
    Cat-Themed Beauty Collection to Launch in Japan
    Pantone Names Classic Blue the 2020 Color of the Year
    Happi

    Latest Breaking News From Happi

    Lip Lab Opening in Brooklyn
    Raining Rose Expands Exec Team
    Scott’s Sells Personal Care Production Site
    Ink World

    Latest Breaking News From Ink World

    ePac Flexible Packaging Expands into Asia Pacific Market
    Haney, HP Developing Sustainable Fashion Packaging for Heron Preston
    Addipel Moves to New HQ, Expands Production Facility
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP teams with Haney for sustainable packaging
    Tags & Labels Printing adds Heidelberg’s Versafire EP
    Austrian converter installs first Nilpeter press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    IDTechEx Show! Announces Graphene Award Winner
    OE-A Continues to Bring Future of Printed Electronics to CES 2020
    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS

    Copyright © 2019 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.