Endoskeleton™ TL Hyperlordotic
M333023W095E Rev. B
Interbody System with Titan
nanoLOCK™ Surface Technology
STAND WITH THE FUTURE™
2021-10-14
IMPORTANT INFORMATION ON THE ENDOSKELETON™ TL HYPERLORDOTIC
INTERBODY SYSTEM WITH TITAN NANOLOCK™ SURFACE TECHNOLOGY
DESCRIPTION
The Endoskeleton™ TL Hyperlordotic Interbody System implants are available in a variety of lengths, widths, and heights for
treatment in lateral lumbar interbody fusion and is 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. The design incorporates “windows” through the interbody device to permit visualization of the interbody
device placement, and over time, formation of new bone. New bone formation through the interbody device is intended to
provide long-term structural support and fusion at the implanted disc space. The interbody device is treated with Titan Surface
Technologies™, where nanoLOCK™ Surface Technology (MMN™) is 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
demonstrated the 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.
The lateral plate and bone screws are available in a variety of sizes for stabilizing the interbody device. The lateral plate has one
or two holes for receiving integrated bone screws and a feature for attachment to the interbody device. The lateral plate
incorporates a lock cover to resist the integrated bone screws from backing out. The interbody device and associated device
components are composed of ASTM F136 or ASTM F3001 Ti6Al4V ELI titanium alloy and are provided sterile.
The Endoskeleton™ TL 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
INDICATIONS
The Endoskeleton™ TL Hyperlordotic Interbody System (≥16˚) devices with macro-, micro-, and nano-roughened surface
textured features are indicated for use 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. 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 Endoskeleton™ TL Hyperlordotic Interbody System. Patients with
previous non-fusion spinal surgery at the involved levels may be treated with the device. The Endoskeleton™ TL Hyperlordotic
Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis
and sagittal deformity. The interbody 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™ TL Hyperlordotic Interbody System must be used with an integrated lateral plate and bone screw and
additionally must be used with 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.
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
▪ Endoskeleton™ TL Hyperlordotic Interbody System implants and associated components should never be implanted in
patients with a systemic or local infection.
▪ Endoskeleton™ TL Hyperlordotic Interbody System implants should not be used with components of other interbody
systems. Posterior supplemental internal spinal fixation cleared by the FDA for use in the lumbar spine must be used.
▪ The Endoskeleton™ TL Hyperlordotic Interbody System should not be implanted in 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
Hyperlordotic Interbody System.
▪ The Endoskeleton™ TL Hyperlordotic Interbody System should not be implanted in patients with a 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™ TL Hyperlordotic Interbody System implants and
associated components, 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 material.
▪ 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 obtainable
correction, amount of mechanical fixation, and/or quality of the bone graft).
▪ Long term systemic corticosteroid use.
▪ Active drug abuse.
▪ Cases requiring mixing 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 prior to 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.
▪ 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 mating instrument. On all
threaded connections, provisionally (finger) tighten only.
POSTOPERATIVE
▪ The physician’s postoperative directions, 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 the interbody device or associated components loosen, bend, and/or break, the construct
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 interbody devices and associated components 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
instructions. The Endoskeleton™ TL Hyperlordotic Interbody System implants are provided sterile. Endoskeleton™ TL
Hyperlordotic Interbody System instruments are provided non-sterile and must be cleaned and sterilized prior to use.
Thoroughly clean the long, narrow, blind holes and lumens carefully. Clean instruments as soon as possible after use and
sterilize. Repeat cleaning if instrumentation is 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™ TL Hyperlordotic
instruments 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™ TL Hyperlordotic 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
Hyperlordotic Interbody System in the MR environment is unknown. Scanning patients who have this device 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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