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Orthofix has received 510(k) clearance for expansion of its FIREBIRD SI fusion system. According to the February 12, 2015 news release, The topography consists of a unique combination of roughened topographies at the macro, micro, and cellular levels. All Rights Reserved. FundamentalVR adds Teaching Space to its Fundamental Surgery platform as a virtual classroom. Literature Part Number 60-0020, Rev02. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), and creating the potential for a faster and more robust fusion., Titan President Kevin Gemas commented, We are proud to launch the Endoskeleton TCS as the latest addition to our surface engineered interbody device portfolio that continues to challenge the status quo in the interbody fusion marketplace. Privacy Policy, Winner of the MORE Award in Journalistic Excellence in Orthopedics. Titan Spine, LLC is celebrating the receipt of a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the release its Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation. It is part of the fusion process in that it creates an osteogenic response to the implants topography. Titan Spine, LLC is celebrating the receipt of a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the release its Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation. Learn how your comment data is processed. Most importantly, our surface is created through a proprietary subtractive process rather than an additive coating, which eliminates the potential for delamination and/or particulate debris when compared to products with a PEEK-titanium interface., The Endoskeleton TCS device is designed for integrated fixation with two surface-enhanced screws that provide for immediate implant mechanical stability. The screws incorporate an anti-backout feature that do not lock the screws to the implant and allow up to 39 degrees of medial-lateral (M/L) and 29 degrees of anterior-posterior (A/P) angulation post-implantation., Chief Medical Officer Paul Slosar, M.D. Endoskeleton TCS / Source: Titan Spine, LLC. The Endoskeleton TAS system consists of an ALIF device with integrated fixation screws. Please refer to package insert for current warnings, precautions, and instructions for use. The Titan Spine ENDOSKELETON TAS or ENDOSKELETON TAS Hyperlordotic Interbody Fusion Systems have not been evaluated for safety and compatibility in the MR environment. ENDOSKELETON TAS - SIZING ENDOSKELETON TL Lateral Fusion Device for the Lumbar Spine Featuring Surface Technology TL SURGICAL TECHNIQUE TL Notice: One or more products are covered by patents. Dr. Slosar commented to OTW, One of our biggest challenges we encountered while designing the TCS was to maintain the features of our standalone ALIF device that work well while adding an anti-backout feature to the screws. The ENDOSKELETON TAS or ENDOSKELETON TAS Hyperlordotic system should not be used with components of any other interbody systems. Save my name, email, and website in this browser for the next time I comment. Required fields are marked *. These designs support anterior cervical and anterior, posterior, oblique, and lateral approaches to the lumbar spine. Your email address will not be published. Castellvi Covers COVIDs Effect on Elective Surgery and Healthcare, Infinite, Multiuser, VR Surgery Classroom Launched, Infuse Marketing in Australia Under Investigation, FDA Clears Nano Upgrade for SI Fusion System, CoreLink Launches 3D Printed Instrument Set for OLIF System, Patent Awarded for Quadracentric SIJF Procedure, The Cementless Tibia: A Viable Fixation Alternative, Avail Medsystems Raises $100 Million in Series B Funding, IMED Surgical Files Federal Lawsuit Over External Fixation System, Risky Business The Hard and Soft Side of Risk Management, Potentially Game-Changing TKA System Has 1st Surgery, Castellvi Meetings Remarkable Biomechanics/Biomaterials Course, James R. Lawson, Formerly of Stryker, Passes Away at 76, Gene Sequencing Detected Infection 2x Better Than Culture, Breakthrough Designation to NovoPedics Meniscus Replacement, Biorez Raises $3.5 Million and Launches New Website, Alphatec Has Partial Victory in Court Battle With NuVasive, Medacta Receives Clearance to Expand Shoulder System, No Advantage to Rifampin Combination Therapy in PJI.

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