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Talk with your doctor and family members or friends about deciding to join a study. 0000005806 00000 n
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Safety and effectiveness has not been established in patients with the following conditions: morbid obesity; symptomatic cardiac disease; pregnancy; signs of local inflammation; fever or leukocytosis; metal sensitivity/allergy to the implant materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and/or the quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with anatomical structures or expected physiological performance. 0000359575 00000 n
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Supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used. When threading components together, keep to the thread axis. 0000029308 00000 n
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Shepherd said that Titan Spine’s Endoskeleton implants feature a proprietary acid-etched surface that is textured at the macro, micro and cellular levels to support bone purchase and new bone growth. 0000005531 00000 n
The Endoskeleton TT device should not be implanted in patients with an allergy to titanium or titanium alloys. The implants should not be scratched or otherwise damaged. This site uses cookies to store information on your computer.
Other conditions may exist where safety and effectiveness have not been established.
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The Endoskeleton TT Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. 0000004226 00000 n
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Subject must understand and sign the written Informed Consent. As with all orthopedic implants, the Endoskeleton TO Interbody Fusion Device should never be reused under any circumstances. 0000014932 00000 n
Update my browser now. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. If threads are damaged, set the product aside and do not use. On all threaded connections, finger tighten only. C� C�:&��[#�N8�U 0000006688 00000 n
All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. 0000578822 00000 n
The Endoskeleton TT Interbody Fusion Device implants are available in a curved shape and 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 … 0000412866 00000 n
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The type of construct to be assembled for the case should be determined prior to beginning the surgery. Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule. The nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale features. 0000005903 00000 n
The population will be drawn from an existing patient population per participating site. On all threaded connections, finger tighten only. Based on fatigue testing results, when using the Endoskeleton TO Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. 0000200087 00000 n
osteomalacia, gout, Paget's disease etc. The Titan Spine Endoskeleton TT Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. Damage to nerves may occur resulting in loss of neurological functions. Interbody Science Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. The risk of bending, loosening or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use crutches or other such weight supporting devices. 0000042658 00000 n
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This is a prospective, multi-center controlled observational clinical study. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. 0000044397 00000 n
Predicate Devices): The superior and inferior surfaces include either the Chemtex™ surface treatment or nanoLOCK surface treatment (MMN) designed to improve fixation to the adjacent bone. Internal and external threads on instruments can be damaged by cross-threading. The design incorporates “windows” through the implant to permit visualization of the graft material and over time formation of new bone. The Endoskeleton TO Interbody Fusion Device should never be implanted in patients with a systemic or local infection. <<0E3CD2AEA6EA364C83582E0770918A54>]/Prev 1043697>>
Macro textures on the superior and inferior surfaces promote immediate mechanical fixation. Patient conditions and/or predispositions such as these should be avoided. Previous history of fusion surgery at the index level(s). Titan Endoskeleton Posterior Lumbar Products, Titan Endoskeleton Posterior Lumbar Products. 0000009541 00000 n
At all times, extreme caution should be used around the spinal cord and nerve roots. 0000040688 00000 n
The design incorporates “windows” through the implant to permit visualization of the graft material, and over time, formation of new bone. 0000213766 00000 n
Devices should be routinely inspected; if they exhibit wear, damage, corrosion, or discoloration they should be returned to Titan Spine for further evaluation. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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