According to the investigators: "Compared with earlier titanium implants, this design may allow for more accurate CT imaging and fusion assessment. Titan Original Surface wins an OTW Best Technology Award. Titan Spine, Inc. August 29, 2019 Christine Scifert Exec VP MRC/X, LLC 6075 Poplar Ave. Memphis, Tennessee 38119 Re: K192054 Trade/Device Name: Endoskeleton TAS Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 30, 2019 . If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information. Designed to Accommodate Optimal TLIF Placement Why Should I Register and Submit Results? How will market shares and the Status Quo change in the Spine market? Endoskeleton TO Interbody Fusion Device - K170399 Endoskeleton TA Interbody Fusion Device - K080615 Surgicraft STAFLIF TT - K073109 Endoskeleton Interbody Fusion Devices - K192018 Reference Predicates: Titan Spine Allograft Indications update - K183557 Titan Spine Sterile TAS / TCS screws - K173535 K191581 Page 1 of 3 After some days, What is our take on the merger Globus-Nuvasive? Please remove one or more studies before adding more. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. Ghost Productions provided Titan Spine with an technique animation of its Endoskeleton device. August 2016 hZko+1Aor'^#m`Mx Kl~F@3>.s$TJHCE+gR*Z>Xo"*:K*uU2sh*X9_ ?. The Titan Endoskeleton surface uses subtractive manufacturing to create unique textures at the macro and micro levels. Endoskeleton is an anterior vertebral body replacement device. 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Spinal & Orthopaedic The subject devices . June 2019 All rights reserved. Distributors were advised to examine their inventory and quarantine the product. TEL: +1 949 723 9309 View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with integrated fixation screws. An implant holding feature was incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the interbody space. We feel that we are well positioned to continue to increase our market share and meet the growing need of spine surgeons looking for innovative interbody implants that create a superior osteogenic environment for their patients.. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Spine. The researchers say it will be the worlds first MRI scanner with a magnetic field [], We love engineers here at DeviceTalks. To provide the best experiences, we use technologies like cookies to store and/or access device information. A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or tensioning of a nut during a surgical procedure. Talk with your doctor and family members or friends about deciding to join a study. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA. 34 This is a reusable device. MEQUON, Wis.- (BUSINESS WIRE)-Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has. Dr Kingsley R Chin Warns Against Expert Surgeon Witnesses Supporting Copycat Pedicle Screw Lawsuits. You have reached the maximum number of saved studies (100). BIBA Medical, North America I look forward to adding the TAS to my practice., Kevin Gemas, president of Titan Spine, commented, The addition of the Endoskeleton TAS to our product line now allows us to address approximately 90% of the interbody market that is approaching US$1 billion in domestic annual sales. Anti-expulsion texturing on superior and inferior surfaces. Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home . I look forward to adding the TAS to my practice., Kevin Gemas, President of Titan Spine, commented, The addition of the Endoskeleton TAS to our product line now allows us to address approximately 90% of the interbody market that is approaching $1 billion in domestic annual sales. Editor: Anthony Strzalek [emailprotected] Therapies & Procedures Interbody Products Rough titanium alloys regulate osteoblast production of angiogenic factors. $12M Verdict Against DePuy Synthes for Spinal-Fusion Patent Infringement. With an updated browser, you will have a better Medtronic website experience. Email: [emailprotected] About the Company Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. Solutions . The technical storage or access that is used exclusively for statistical purposes. Front Bioeng Biotechnol. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site. One of the first implantations of the Endoskeleton TAS was conducted by Dr. Robert Henderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. Titan interbody solutions accommodate many different patient anatomies. Integrated Fixation This increases the filtering performance in prolonged use of the mask for up to four [], Engineers at the Massachusetts Institute of Technology have developed a 3D-printed heart replica that pumps and looks like a human heart. Titan Endoskeleton. Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule. The technical storage or access that is used exclusively for anonymous statistical purposes. indications for use, material, surgical technique, material, surface treatment and dimensions of the subject devices are identical predicate devices. Its obvious why. Interestingly the company does not state whether it has CE mark approval for the device, although we note they are exhibiting at Eurospine in Milan this week. Endoskeleton TAS ALIF VIDEO ANIMATION (Old version of Titan Spine), Anterior Lumbar Interbody Fusion Cages (ALIF), Globus Medical and NuVasive to Combine in All-Stock Transaction to Create Innovative Global Musculoskeletal Company Focused on Patient Care. It also actively monitors the healing process and harmlessly dissolves with its electrodes into the body once no longer needed. The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. Powered by Madgex Job Board Software, Unique Implant Incorporates Integrated Screws that Prevent the Need for Supplemental Fixation. About the Company Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. Thats not to say there havent been job cuts in medtech, led by thousands of layoffs [], Northwestern University engineering researchers say they developed a first-of-its-kind small, flexible, stretchable electronic bandage. Intuitive instrumentation, and large windows allow for easy insertion and assessment of placement both in situ and after the procedure. Joe Rowan has retired as CEO and president of Junkosha USA but will remain as an advisor as Mike Winterling takes over as chief operating officer. In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention. In vitro studies indicate that this surface may upregulate significantly critical bone growth factors necessary for fusion. Titan interbody fusion devices from Medtronic are available with both Endoskeleton surface features on the endplate contacting faces and with nanoLOCK surface features on all internal and external surfaces. K173535 Page 2 of 3. differ from the predicate devices in the . Healthcare Professionals How these engineers make DeviceTalks Boston go. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V- ELI). : refer to the Data Element Definitions if submitting registration or Results information extender to be used in enrolled! An technique animation of its Endoskeleton device for Supplemental Fixation members or friends deciding... 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