With an updated browser, you will have a better Medtronic website experience. This is a reusable device. xr\lY'~00)"f~tu|fm]65of_n7'ys:'/|S=yT'M3&DW:2!~t+x6_-fEa|g9dGezL^(|+)qY5/_',Wd}9&o7&X]#E)jvY&lGlx5]7,2='~6.~] Company Name: TITAN SPINE, LLC Primary DI Number: 00191375050445 Issuing Agency: GS1 Commercial Distribution End Date: February 24, 2021 Device Count: 1 . Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910309.
Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home . I was particularly impressed with the purchase of the screws and how the roughened surface of the implant prevented the device from moving during screw insertion, said Dr. Geisler. Toggle navigation. The Endoskeleton TAS incorporates the same macro, micro, and nano surface textures asthe companys Endo TA ALIF device, which has been shown to elicit a superior osteogenic response in comparison to other commercially available interbody materials. Lundi au vendredi de 05h10 20h20. For general information, Learn About Clinical Studies. One of the first implantations of the Endoskeleton TAS was conducted by Dr. RobertHenderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Schneider, J.M., Haithcock, D., Ullrich, P., Schwartz, Z., Boyan, B.D. The disc material is then replaced by cage containing bone graft or bone morphogenetic protein.The ALIF cage maintains normal disc height as the bone graft fuses with the bone of the vertebrae above and below to stabilize the spine. Create and promote branded videos, host live events and webinars, and more. 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
Interbody Science
Is there too much of a conflict of interest between industry Spinal News Internationals top 10 most popular stories of January 2023, Spinal News Internationals top 10 most popular stories of December 2022. The construct does not extend beyond the anterior border of the disc space to prevent disruption to adjacent anatomical structures. Devices incorporate Titan Surface Technologies, where superior and inferior surfaces include either Chemtex or nanoLOCK surface treatments (MMN) designed to improve fixation to the adjacent bone. Full Range of Sizes M/L x A/P= 30 x11 mm or 35 x11 mm New bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space.
Agenda complet. The population will be drawn from an existing patient population per participating site. MedTech 100 is a financial index calculated using the BIG100 companies covered in
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
This is a prospective, multi-center controlled observational clinical study. Degenerative Disc Disease, Spondylolisthesis, Device: TLIF with Titan TT/TO interbody cage. Get the latest updates about interbody science, training, and events. Human mesenchymal stem cell morphology and migration on microtextured titanium. Check your inbox or spam folder to confirm your subscription. Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. 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. Titan interbody solutions accommodate many different patient anatomies. 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 . Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. www.titanspine.com, 1985 - 2023 BioSpace.com. In addition, the TAS features three integrated grit-blasted screws that allow up to ten degrees of medial/lateral or anterior/posterior angulation.
Please remove one or more studies before adding more. Increasing demand for posterior spinal fusion procedures will strain healthcare systems, Boston Scientific announces three-month data from SOLIS trial at NANS. )\'0mjT!(Gx_W!Y*2U0%*6 U5.
Previous history of fusion surgery at the index level(s). Endoskeleton is an anterior vertebral body replacement device.
The letters described the problem and the product involved in the recall. It does not include a torque-limiting mechanism. Contact us for customer service, reimbursement support, and more. Titan Spine Endoskeleton TAS Interbody Fusion Device (K163269, S.E. ), 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). Therapies & Procedures Designed to Help Facilitate a Smooth and Accurate Placement
Endoskeleton TAS ALIF VIDEO ANIMATION (Old version of Titan Spine)
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.
Update my browser now. Is there too much of a conflict of interest between industry and RCTs? Terms and Conditions | Privacy Policy. Why Should I Register and Submit Results? Titan Spine is touting the results of a new study demonstrating a reduced subsidence rate and overall subsidence amount of its Endoskeleton TA device compared to a commercially available PEEK device. One hundred and fifty (150) subjects will participate in the study at a max of 15 clinical sites. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin. . spinemarketgroup@gmail.com info@thespinemarketgroup.com. Durham, North Carolina-based Isolere Bio develops new and proprietary IsoTag reagents and filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals. It is a nice option to have for specific spinal pathologies where supplemental posterior stabilization can be avoided. Dr. Fred Geisler, Neurosurgeon with The Chicago Back Institute in Chicago, Illinois, was also one of the first surgeons to implant the device. 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. Get the latest business insights from Dun & Bradstreet. 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. Interbody Products Banik, B., Riley, T., Platt, C., Brown, J. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Integrated Fixation Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Any other concurrent medical disease that might impair normal healing process. Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. The letters described the problem and the product involved in the recall. 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.. Home; App Suite; . The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes. Healthcare Professionals Steve Cichy, 866-822-7800
The radiopaque nature of titanium assists in device placement. Three integrated, grit-blasted screws provide immediate mechanical stability. How are the Top Spine Companies performing in 2022 so far? 203 0 obj
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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). 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.
In addition, the TAS features three integrated grit-blasted screws that allow up to ten degrees of medial/lateral or anterior/posterior angulation. 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. 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. Spinal & Orthopaedic nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale features. The Endoskeleton TT is a titanium alloy interbody device designed to aid in the fusion of 1 or 2 contiguous levels between L2 and S1 through a TLIF.This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. 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
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To provide the best experiences, we use technologies like cookies to store and/or access device information. 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. Titan Endoskeleton TT and OsteoSponge/BMA. 04/13/2017) Additional Predicates . Cages are designed without ridges and teeth, so interbodies do not damage the vertebral endplate and avoid subsidence. Home Its obvious why. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. 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. 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