L'accs aux quais reste possible en dehors de ces horaires. spinemarketgroup@gmail.com info@thespinemarketgroup.com. LARGE WINDOWS AND INTERNAL VOLUMES 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., Write to us Two grit-blasted anti-backout or standard screws provide immediate mechanical stability. ), Osteoporosis defined as a DEXA bone density measurement T score 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care). BIBA Medical, North America Screws include internal hex drive features matched to instrumentation for implantation. What differentiated products does Nuvasive bring to Globus Medical? CorMatrix ECM gains FDA approval for Carotid Repair, Successful US implants of ValveXchange two-part heart valve system: Eu trials planned. Increasing demand for posterior spinal fusion procedures will strain healthcare systems, Boston Scientific announces three-month data from SOLIS trial at NANS. Founded in2006, the company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, TITAN SPINE LLC - ENDOSKELETON TAS : Product Information, TITAN SPINE LLC - ENDOSKELETON TAS : Product Code Information, Labeling does not contain MRI Safety Information. Endoskeleton is an anterior vertebral body replacement device. Investigational drug or device use within 30 days. Unique Implant Incorporates Integrated Screws that Prevent the Need for Supplemental Fixation 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 received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with . 155 North Wacker Drive, Suite 4250, Chicago, IL 60606 I look forward to adding the TAS to my practice., Kevin Gemas, President of Titan Spine, commented, The addition of the EndoskeletonTAS to our product line now allows us to address approximately 90% of the interbody market that is approaching $1 billion in domestic annual sales. One of the first implantations of the Endoskeleton TAS was conducted by Dr. RobertHenderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. Video marketing. Full Range of Sizes M/L x A/P= 30 x11 mm or 35 x11 mm TEL: +1 949 723 9309 The Implants are designed with a large hollow region in the center to house autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy . Read our, ClinicalTrials.gov Identifier: NCT03910309, A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis, 18 Years to 75 Years (Adult, Older Adult), Daly City, California, United States, 94051, degenerative disc disease, spondylolisthesis, Pain measured by VAS [TimeFrame:2 years], Function measured by oswestry disability index [TimeFrame:2 years], Success of fusion [TimeFrame:3 months, 6 months, 12 months, 24 months], Be 18-75 years of age, and skeletally mature. Ehlers-Danlos syndrome associated with higher medical and surgical complications following ACDF, Increasing demand for posterior spinal fusion procedures will strain healthcare systems, new study suggests, NuVasive and Globus Medical announce merger. Cages are designed without ridges and teeth, so interbodies do not damage the vertebral endplate and avoid subsidence. Email: [emailprotected] In addition, the TAS features three integrated grit-blasted screws that allow up to ten degrees of medial/lateral or anterior/posterior angulation. Titan becomes the first to commercialize nanotechnology for the spine. I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. Degenerative Disc Disease, Spondylolisthesis, Device: TLIF with Titan TT/TO interbody cage. 34 This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. Home The letters described the problem and the product involved in the recall. In addition, the TAS features three integrated grit-blasted screws that allow up to ten degrees of medial/lateral or anterior/posterior angulation. Anti-expulsion texturing on superior and inferior surfaces. Titan Products. Healthcare Professionals Information provided by (Responsible Party): This is a prospective, multi-center controlled observational clinical study. Designed to Help Streamline Workflow and Placement The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Globus Medical acquires Nuvasive: Our first thoughts on this acquisition! 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. 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. Titan introduces its first generation surface technology for titanium interbodies to the market. It does not include a torque-limiting mechanism. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media. Dr Kingsley R Chin Warns Against Expert Surgeon Witnesses Supporting Copycat Pedicle Screw Lawsuits. Powered by Madgex Job Board Software, Unique Implant Incorporates Integrated Screws that Prevent the Need for Supplemental Fixation. Robert Henderson, orthopaedic surgeon at Dallas Spine Care in Dallas, Texas, USA, performed one of the first implantations of the Endoskeleton TAS, he commented, I felt the procedure went very well and the surgical technique was simple and straightforward.. How these engineers make DeviceTalks Boston go. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. Insert pedicle screws more precisely and safely without a robot or navigation system? Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, M/L x A/P= 14 x12 mm (Small), 16 x14 mm (Medium), or 18 x16 mm (Large), L = 22 mm (0 or 4), 26 mm (0 or 4), or 31 mm (0 only), M/L x A/P= 32 x21 (Standard), 36 x 24 (Large), or 40 x 27 mm (X-Large), M/L x A/P= 32 x21 (Standard), 36 x 24 (Large). 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 Talk with your doctor and family members or friends about deciding to join a study. (UPDATED 2023): +100 Percutaneous Screw MIS Systems to Know! Human mesenchymal stem cell morphology and migration on microtextured titanium. WTWH Media LLC and its licensors. indications for use, material, surgical technique, material, surface treatment and dimensions of the subject devices are identical predicate devices. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. 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July 2014 (www.medtronic.com), Filed Under: Anterior Lumbar Interbody Fusion Cages (ALIF). Designed to Help Facilitate Ease of Placement for Both TLIF and PLIF Trajectories The regulatory clearance is the fifth such approval for the company and supplements its current line of TLIF, PLIF, ALIF, andcervical interbody implants. The new agreement builds on an existing relationship between Ricoh 3D [], These 10 medtech companies have spent the largest share of their annual sales on R&D, according to Medical Design & Outsourcings annual Big 100. 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. The design incorporates windows through the implant to permit visualization of the graft material, and over time, formation of new bone. The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user. Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Rough titanium alloys regulate osteoblast production of angiogenic factors, Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors, Human mesenchymal stem cell morphology and migration on microtextured titanium, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Titan Spine's technology centers around a proprietary surface treatment that creates a textured surface at the macro, micro and cellular levelsa combination the firm claims promotes new bone growth to support the fusion process. 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. Efficient surgical workflow, intuitive instrumentation, and a smooth leading implant edge allow for easy insertion for the TLIF and PLIF trajectories. Advised consignees to complete and return the enclosed response form. Interbody Science Check your inbox or spam folder to confirm your subscription. Are you a Medical Device Company? hZko+1Aor'^#m`Mx Kl~F@3>.s$TJHCE+gR*Z>Xo"*:K*uU2sh*X9_ ?. To provide the best experiences, we use technologies like cookies to store and/or access device information. RADIOPACITY "It is my belief that surface technology is the next significant innovation for spinal fusions due to the ability to affect a cellular response that promotes a more favourable osteogenic . Interbody Science Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S1. FULL RANGE OF SIZES Services may be provided by Western Union Financial Services, Inc. NMLS# 906983 and/or Western Union International Services, LLC NMLS# 906985, which are licensed as Money Transmitters by the New York State Department of Financial Services. (UPDATED 2022): +20 Expandable Lateral Cages to Know! New bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Spinal & Orthopaedic 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 received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with integrated fixation screws. 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. Instructions for Downloading Viewers and Players. Precisely titan endoskeleton tas surgical technique safely without a robot or navigation system enclosed response form and microlevel... Leading implant edge allow for easy insertion for the legitimate purpose of storing preferences that not. 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