Endoskeleton™ TAS lnterbody
M333023W104E Rev. C
System
Endoskeleton™ TAS Hyperlordotic
Interbody System
STAND WITH THE FUTURE™
2021-10-05
IMPORTANT INFORMATION ON THE ENDOSKELETON™ TAS INTERBODY SYSTEM
AND ENDOSKELETON™ TAS HYPERLORDOTIC INTERBODY SYSTEM
Note: not all parts may be available in each geography.
DESCRIPTION
Endoskeleton™ TAS Interbody System and Endoskeleton™ TAS Hyperlordotic Interbody System implants are available in a
variety of anterior lumbar interbody fusion (ALIF) sizes with a variety of lordotic angles to accommodate patient anatomy.
Hyperlordotic implants are those defined by a lordotic angle ≥16˚. 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 and fusion at the implanted disc space. 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 treatments (MMN™) designed to
improve fixation to the 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
to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered a
nanotechnology as outlined in the FDA nanotechnology guidance document.
The implant system includes integrated fixation (screws) for stabilizing implants when placed in the interbody space. Implantable
components are manufactured from medical grade titanium alloy (Ti6Al4V- ELI).
The Endoskeleton™ TAS Interbody System or Endoskeleton™ TAS Hyperlordotic Interbody System should only be implanted
by surgeons experienced in the use of such implants and the required specialized spinal surgery techniques.
-9
) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed
INDICATIONS
The Endoskeleton™ TAS Interbody System device including those with macro-, micro-, and nano-roughened surface textured
features are indicated for use in skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as
discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative
spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of
interbody fusion. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Patients
should have received 6 months of non-operative treatment prior to treatment with the devices. The device is a standalone
system intended to be used with the bone screws provided and requires no additional supplementary fixation. Endoskeleton™
TAS Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative
scoliosis and sagittal deformity. However, when used in these patients at multiple levels and for patients with degenerative
spondylolisthesis and spinal stenosis at one or two adjacent levels, the Endoskeleton™ TAS Interbody System must be used
with a supplemental internal spinal fixation system (e.g. pedicle screw system) cleared by the FDA for use in the lumbar spine in
addition to the integrated screws. The device is indicated to be used with autograft bone, allograft bone comprised of cancellous
and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
Indications for Hyperlordotic Devices ≥16˚
Endoskeleton™ TAS Hyperlordotic Interbody System (≥16˚) devices including those with macro-, micro-, and nano-roughened
surface textured features are indicated for use in skeletally mature patients with DDD, degenerative spondylolisthesis, and/or
spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients
may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Implants can also be used as an adjunct to
fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Patients should have received 6
months of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone,
allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a
combination thereof. The Endoskeleton™ TAS Hyperlordotic Interbody System must be used with a posterior supplemental
internal spinal fixation cleared by the FDA for use in the lumbar spine.
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.
Endoskeleton™ TAS Interbody System and Endoskeleton™ TAS Hyperlordotic Interbody System implants were 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 interbody systems.
▪ 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™ TAS
Interbody System.
▪ Patients with prior fusion at the levels 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™ TAS Interbody System or Endoskeleton™ TAS
Hyperlordotic Interbody System, the physician/surgeon should consider 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 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 obtainable
correction, amount of mechanical fixation, and/or quality of the bone graft).
▪ Long term systemic corticosteroid use.
▪ Active drug abuse.
▪ 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 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 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 potential consequences.
▪ Postoperative care is important. Patients should be instructed in the limitations of implants and should be 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.
▪ To allow maximum chances for a successful surgical result, patients and implants should not be exposed to mechanical
vibrations that may loosen implants. Patients should be warned of this possibility and instructed to limit and restrict physical
activities, especially lifting, twisting motions, and any type of sport participation. Patients should be advised not to smoke or
consume alcohol during the bone graft healing process.
▪ Patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this
permanent physical restriction on body motion.
▪ If a nonunion develops or if implants loosen, bend, and/or break, implants should be revised and/or removed immediately
before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated
stresses on implants. By the mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of
implants. It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and
confirmed by roentgenographic examination. Patients must be adequately warned of these hazards and closely supervised
to ensure cooperation until bony union is confirmed.
▪ Retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible.
When explanting and/or disposing of a device, be sure to avoid exposure to bodily substances such as blood, tissue, etc., as
contact could lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects and
needles. Follow your healthcare center’s policy regarding both the disposal of devices and any events of exposure.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
ADVERSE EVENTS
Possible adverse effects include:
▪ Bending, loosening, or fracture of implants or instruments.
▪ Loss of fixation.
▪ Sensitivity to a metallic foreign body, including possible tumor formation.
▪ Skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin
breakdown and/or wound complications.
▪ Nonunion or delayed union.
▪ Infection.
▪ Nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy,
paralysis, and cerebral fluid leakage.
▪ Gastrointestinal, urological, and/or reproductive system compromise including sterility, impotency, and/or loss of
consortium.
▪ Pain or discomfort.
▪ Bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the
vertebra).
▪ Hemorrhage of blood vessels and/or hematomas.
▪ Malalignment of anatomical structures including loss of proper spine curvature, correction, reduction, and/or height.
▪ Bursitis.
▪ Bone graft donor site pain.
▪ Inability to resume activities of normal daily living.
▪ Death.
Note: additional surgery may be necessary to correct some of these potential adverse events.
CLEANING & STERILIZATION
Refer to Reprocessing Instructions for Titan Devices 70-0015 for detailed instruction, including disassembly/assembly and
sterilization instructions. Endoskeleton™ TAS Interbody System or Endoskeleton™ TAS Hyperlordotic Interbody System
implants and screws are provided either sterile or non-sterile. See package labeling for identification. Thoroughly clean
instrumentation, especially the long and narrow lumens, and blind holes carefully. Clean instruments as soon as possible after
use and sterilize. Repeat cleaning if not visually clean. The detergent manufacturer’s instructions should be followed to achieve
correct dilution, temperature, contact time, and water quality. Hospital approved methods should be followed when handling
implants or instruments contaminated with blood, tissue, and/or bodily fluid. The Endoskeleton™ TAS Interbody System and
Endoskeleton™ TAS Hyperlordotic Interbody System must be sterilized in a properly functioning, calibrated steam sterilizer.
The following sterilization cycles (in accordance with ANSI/AAMI ST79 or ISO 14937 and ISO 17665-1) are recommended for
use with FDA-cleared sterilization wraps:
Surgical Case Method Cycle Temperature Exposure time Minimum dry time
Wrapped Steam Pre-vacuum 270°F (132°C) 4 minutes 40 minutes
Wrapped* Steam* Pre-vacuum* 273°F (134°C)* 3 minutes* 40 minutes*
Wrapped Steam Pre-vacuum 275°F (135°C) 3 minutes 40 minutes
* Not considered by the Food and Drug Administration (FDA) to be standard sterilization cycles. It is the user’s responsibility to
use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators,
and sterilization cassettes) cleared by the FDA for the selected sterilization cycle specifications (time and temperature).
MRI INFORMATION
The Endoskeleton™ TAS Interbody System and Endoskeleton™ TAS Hyperlordotic Interbody System were not evaluated for
safety and compatibility in the MR environment. They were not tested for heating, migration, or image artifact in the MR
environment. Safety of the Endoskeleton™ TAS Interbody System and Endoskeleton™ TAS Hyperlordotic Interbody System in
the MR environment is unknown. Scanning patients who have these devices may result in patient injury.
VISUAL INSPECTION
Visually inspect all sterile barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not
use the product. Contact Medtronic for return information.
Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return
information.
PACKAGING
Devices may be supplied sterile or non-sterile. Packages for each of the components should be intact upon receipt. Once the
seal on the sterile package is broken, the product should not be re-sterilized. If a loaner set is used, all sets and components
should be carefully checked for completeness and to ensure there is no damage prior to use. Damaged packages or products
should not be used and should be returned to Medtronic.
PRODUCT COMPLAINTS
For product problems, contact Medtronic.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.
©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Manufacturer
Date of manufacture
Use-by date
Do not re-use
Batch code
Catalogue number
Non-sterile
Sterilized using irradiation
Consult instructions for use at this website.
For US audiences only
*Single sterile barrier system
Double sterile barrier system
Single sterile barrier system with protective packaging
inside
Single sterile barrier system with protective packaging
outside
*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.
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