Endoskeleton™ TA Vertebral Body
M333023W097E Rev. C
Replacement Interbody System
STAND WITH THE FUTURE™
2021-10-04
IMPORTANT INFORMATION ON THE ENDOSKELETON™ TA VERTEBRAL BODY
REPLACEMENT INTERBODY SYSTEM
Note: not all parts may be available in each geography.
DESCRIPTION
Endoskeleton™ TA Vertebral Body Replacement (VBR) Interbody System 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. New bone formation through the implant is intended to provide
long-term structural support to the treated levels. The design incorporates “windows” through the implant to permit visualization
of the graft material and, over time, formation of new bone. Devices incorporate Titan Surface Technologies™, where superior
and inferior surfaces include either Chemtex™ or nanoLOCK™ surface treatment (MMN™) designed to improve fixation to
adjacent bone. nanoLOCK™ surface technology (MMN™) provides a microscopic roughened surface with nano-scale features.
nanoLOCK Surface Technology is specifically engineered to have nano textured features at a nanometer (10
have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured
features in vitro. nanoLOCK surface technology demonstrates elements to be considered a nanotechnology as outlined in the
FDA nanotechnology guidance document. Implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided
either sterile or non-sterile.
The Endoskeleton™ TA VBR Interbody System should only be implanted by surgeons experienced in the use of such implants
and the required specialized spinal surgery techniques.
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) level, which
INDICATIONS
Endoskeleton™ TA Vertebral Body Replacement Interbody System devices including those with macro-, micro-, and nanoroughened surface textured features are for use in the thoracolumbar spine (T1 – L5) in skeletally mature patients replacing all
or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). Endoskeleton™ TA Vertebral
Body Replacement Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel
degenerative scoliosis and sagittal deformity. The Endoskeleton™ TA Vertebral Body Replacement Interbody System is
intended for use with supplemental internal spinal fixation systems cleared by the FDA for use in the lumbar spine. The
Endoskeleton™ TA Vertebral Body Replacement Interbody System may be used with autograft bone, allograft bone comprised
of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
WARNINGS
When using metallic implants, be aware of the following:
▪ Correct selection of implants is extremely important. Potential for success is increased by selection of proper size, shape,
and design of implants.
▪ Correct handling of implants is extremely important. Contouring of implants is to be avoided.
This device was designed for single patient use only. Do not reprocess or reuse this product. Reuse or reprocessing may
compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient
injury, illness, or death.
CONTRAINDICATIONS
▪ Patients with a systemic or local infection.
▪ Use with components of any other corpectomy system. Supplemental fixation cleared by the FDA for use in the lumbar
spine must be used.
▪ Patients with an allergy to titanium or titanium alloys.
▪ All patients should have at least 6 months of non-operative care prior to spinal fusion with the Endoskeleton™ TA Vertebral
Body Replacement Interbody System.
▪ Patients with a prior fusion at the level(s) to be treated.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Based on fatigue testing results, when using the Endoskeleton™ TA Vertebral Body Replacement Interbody System, the
physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions,
etc., which may impact performance of this system.
▪ Safety and effectiveness were not established in patients with the following conditions and/or dispositions which should be
avoided:
▪ Morbid obesity.
▪ Symptomatic cardiac disease.
▪ Pregnancy.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Metal sensitivity and/or allergy to implant materials.
▪ Medical or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as 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.
▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since
this condition may limit obtainable correction, amount of mechanical fixation, and/or quality of the bone graft).
▪ Long term systemic corticosteroid use.
▪ Active drug abuse.
▪ Cases not needing a bone graft or fusion or where fracture healing is not required.
▪ Cases requiring the mixing of metals from different components.
▪ Patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Any time implant use would interfere with anatomical structures or expected physiological performance.
▪ Other conditions may exist where safety and effectiveness were not established.
▪ Care should be used when handling and storing implants and instruments. Implants should not be scratched or otherwise
damaged. Implants and instruments should be protected during storage, especially from corrosive environments. Devices
should be routinely inspected. If they exhibit wear, damage, corrosion, or discoloration they should be returned to
Medtronic.
▪ The type of construct to be assembled for the case should be determined before surgery. An adequate inventory of implant
sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.
▪ Unless sterile packaged, all devices should be sterilized before use. Additional sterile components should be available in
case of an unexpected need.
▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before use and should
personally assemble the devices to verify all parts and necessary instruments are present before surgery.
▪ Proper implant selection greatly affects surgical outcomes. Patients who smoke were shown to have an increased incidence
of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences.
▪ Postoperative care is important. Patients should be instructed in the limitations of implants and cautioned regarding weight
bearing and body stress on the appliance prior to secure bone healing.
INTRAOPERATIVE
▪ Instruction manuals should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting
in loss of neurological functions.
▪ Implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
▪ Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow aspirate, or a
combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone.
▪ Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for
damage prior to assembly. If threads are damaged, do not use. When threading components together, keep to the thread
axis. Screw in the component as far as it will go and ensure the component is flush with the insertion instrument. On all
threaded connections, provisionally (finger) tighten only.
POSTOPERATIVE
▪ The physician’s postoperative directions and warnings to patients and corresponding patient compliance are extremely
important.
▪ Detailed instructions on use and limitations of implants should be given to patients. If partial weight bearing is
recommended or required prior to firm bony union, patients must be warned that bending, loosening or breakage of
implants are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity.
Risk of bending, loosening, or breakage of an internal fixation device during postoperative rehabilitation may be increased if
patients are active, debilitated, demented, or unable to use weight supporting devices. Patients should be warned to avoid
falls or sudden jolts in spinal position.
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