Endoskeleton™ TL Interbody System
M333023W099E Rev. C
STAND WITH THE FUTURE™
2021-10-04
IMPORTANT INFORMATION ON THE ENDOSKELETON™ TL INTERBODY SYSTEM
Note: not all parts may be available in each geography.
DESCRIPTION
Endoskeleton™ TL Interbody System implants are available in a variety of lengths, widths, and heights for treatment in lateral
lumbar interbody fusion 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 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
the Chemtex™ or nanoLOCK™ surface treatments (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
ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK
surface technology demonstrates the 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 are provided either sterile or nonsterile.
The Endoskeleton™ TL 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
INDICATIONS
Endoskeleton™ TL Interbody System devices including those with macro-, micro-, and nano-roughened surface textured
features are indicated for use in spinal fusion procedures in skeletally mature patients with 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also
have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Endoskeleton™ TL Interbody System implants can
also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Patients
with previous non-fusion spinal surgery at the involved levels may be treated with the device. It 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.
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 interbody systems. The device must be used with supplemental fixation cleared by the
FDA for use in the lumbar spine.
▪ 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™ TL 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™ TL 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 the devices to verify all parts and necessary instruments are present before surgery.
▪ Proper implant selection and patient compliance to postoperative precautions greatly affect 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 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™ TL Interbody System implants are provided either sterile or non- sterile. See package
labeling for identification. Thoroughly clean the long, narrow, blind holes and lumens 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 standard and threaded implant
inserters must be disassembled prior to cleaning and sterilization. To disassemble the threaded inserter (7200-1004) and
angled threaded inserter (7200-1046), rotate back cap counterclockwise to release and remove the inner shaft. To disassemble
the standard inserters (collar version) (7200-1118 and 7200-1122) and the angled inserters (collar version) (7200-1043 and
7200-1044), rotate collar in the direction of the arrow indicated on the instrument. The Endoskeleton™ TL 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*
Surgical Case Method Cycle Temperature Exposure time Minimum dry time
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™ TL Interbody System was not evaluated for safety and compatibility in the MR environment. It was not
tested for heating, migration, or image artifact in the MR environment. The safety of the Endoskeleton™ TL 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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