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. 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. 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. 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. 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. ), 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). Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Intervertebral fusion device with integrated fixation, cervical, Code of Federal Regulations (CFR) Title 21 7.55, 510(K)s with Product Code = OVE and Original Applicant = TITAN SPINE, LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Endoskeleton Locking Bone Screw Assembly. L'accs aux quais reste possible en dehors de ces horaires. 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. 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. How will market shares and the Status Quo change in the Spine market? Interbody Products Create and promote branded videos, host live events and webinars, and more. Nothing happens financing, manufacturing, approval, help for patients without a well-conceived product. Endoskeleton TAS ALIF VIDEO ANIMATION (Old version of Titan Spine) Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S1. Study record managers: refer to the Data Element Definitions if submitting registration or results information. All subjects will have been diagnosed with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon.Subjects will be offered the opportunity to participate in the trial if he/she is determined to be a candidate for TLIF fusion surgery. Two inserter designs that accommodate straight and curved attachment, final positioning instrumentation, and a smooth leading implant edge allow for ease of insertion for the TLIF approach. Are you a Medical Device Company? To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Terms and Conditions | Privacy Policy. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Engineers are the straw that stirs medtechs drink (apologies to Reggie Jackson). 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 . Integrated Fixation The radiopaque nature of titanium assists in device placement. Get the latest business insights from Dun & Bradstreet. Le Gymnase CDCN uvre depuis quarante ans au soutien et au maillage du secteur chorgraphique sur la mtropole lilloise, ainsi que sur le territoire rgional et national. hZko+1Aor'^#m`Mx Kl~F@3>.s$TJHCE+gR*Z>Xo"*:K*uU2sh*X9_ ?. (www.medtronic.com), Filed Under: Anterior Lumbar Interbody Fusion Cages (ALIF). 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. 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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'. The researchers sought to test the Titan Spine ENDOSKELETON implant, which features a large footprint and a wide central aperture for bone graft. Was the Globus Medical merge with Nuvasive an expensive deal? Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site. The Endoskeleton TAS system consists of an ALIF device with integrated fixation screws. Titan interbody solutions accommodate many different patient anatomies. Why are Sales Reps a key piece in the success of the Globus and Nuvasive merger? The 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. Therapies & Procedures Aimed initially at the purification of viral vectors used for cell and gene [], Hear from Medtech Colors 10 Pitch Competition finalists; Kwame Ulmer joins us for the Newsmakers. Japanese fluoropolymer supplier Junkosha today announced new leadership for its U.S. subsidiary. %PDF-1.7 % 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. 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. Zero Profile United States: Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule. Investigational drug or device use within 30 days. Email: [emailprotected] Any other concurrent medical disease that might impair normal healing process. Stratasys patient-specific 3D solutions use 3D printing technology from Stratasys, cloud-based Segmentation-as-a-Service solution from Axial3D and precision additive manufacturing services from Ricoh into one convenient solution. In vitro studies indicate that this surface may upregulate significantly critical bone growth factors necessary for fusion. Contact us for customer service, reimbursement support, and more. 2015 Mar; 40(6): 399-404. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910309. Distributors were advised to examine their inventory and quarantine the product. The construct does not extend beyond the anterior border of the disc space to prevent disruption to adjacent anatomical structures. ENDPLATE-SPARING DESIGN What differentiated products does Nuvasive bring to Globus Medical? Titan gains a Nanotechnology New Technology code from CMS. K173535 Page 2 of 3. differ from the predicate devices in the . The original Titan Endoskeleton surface is supported by a growing body of peer-reviewed literature. 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.. indications for use, material, surgical technique, material, surface treatment and dimensions of the subject devices are identical predicate devices. The letters described the problem and the product involved in the recall. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. Titan becomes the first to offer surface technology on a lateral interbody device. AccessGUDID - ENDOSKELETON TAS (00191375050445)- Plate Inserter, Oblique. 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. These designs support anterior cervical and anterior, posterior, oblique, and lateral approaches to the lumbar spine. LARGE WINDOWS AND INTERNAL VOLUMES The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. Banik, B., Riley, T., Platt, C., Brown, J. 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. 155 North Wacker Drive, Suite 4250, Chicago, IL 60606 osteomalacia, gout, Paget's disease etc. Cages are designed without ridges and teeth, so interbodies do not damage the vertebral endplate and avoid subsidence. 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. Osseus Announces First Ever FDA Standalone Indication for Integrated ALIF with Alternative Fixation. Note: If you need help accessing information in different file formats, see Which Spine products have been launched in 2022? The Endoskeleton TAS incorporates the same macro, micro, and nano surface textures as the companys Endo TA ALIF device, which has been shown to elicit a superior osteogenic response in comparison to other commercially available interbody materials. Solutions . According to the investigators: "Compared with earlier titanium implants, this design may allow for more accurate CT imaging and fusion assessment. 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. Altered the interbody fusion Cages ( ALIF ) new leadership for its U.S..... Features a large footprint and a wide central aperture for bone graft recall! If submitting registration or results information Standalone Indication for integrated ALIF with Alternative.! 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