Medtronic 7300-0116-S Instructions for Use

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.

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) 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.