Medtronic 1378-030-001 Instructions for Use

Endoskeleton™ TCS Interbody

M333023W071E Rev. B

System

STAND WITH THE FUTURE™

2021-10-01

IMPORTANT INFORMATION ON THE ENDOSKELETON™ TCS INTERBODY SYSTEM

Note: not all parts may be available in each geography.

DESCRIPTION

The Endoskeleton™ TCS Interbody System implants are available in a variety of sizes and is designed with a large hollow
region in the center to house bone graft material. 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
have 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. New bone formation through the implant is intended to provide long-term
structural support and fusion at the implanted disc space. The Endoskeleton™ TCS Interbody System includes integrated
fixation screws for stabilizing implants when placed in the interbody space. Implants and associated device components are
composed of ASTM F136 Ti6Al4V ELI titanium alloy and are provided either sterile or non-sterile.

The Endoskeleton™ TCS Interbody System plate is only compatible with the Endoskeleton™ TCS Interbody System product.
The design incorporates a locking screw to secure the plate to the interbody fusion device and is engaged after the plate is
placed on the anterior face of the Endoskeleton™ TCS Interbody System to resist the integrated screws from backing out. The
system includes a holding feature on the plate to mate with the inserter to facilitate placement onto the Endoskeleton™ TCS
Interbody System implant. These plates are optional and do not qualify as supplemental fixation.

The Endoskeleton™ TCS 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

INDICATIONS

The Endoskeleton™ TCS Interbody System devices including those with macro-, micro-, and nano-roughened surface textured
features are intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration
and/ or cervical instability as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy,
and/or pain at multiple contiguous levels from C2 to T1. 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 device is a stand-alone system when used with Endoskeleton™ TCS Interbody System integrated screws. When
used without integrated screws, the device requires additional supplemental fixation cleared by the FDA for the cervical 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

▪ The Endoskeleton™ TCS Interbody System should never be implanted in patients with a systemic or local infection.
▪ The Endoskeleton™ TCS Interbody System should not be used with components of other interbody systems.
▪ The Endoskeleton™ TCS Interbody System should not be implanted in patients with an allergy to titanium or titanium alloys.
▪ All patients should have at least 6 weeks of non-operative care prior to spinal fusion with the Endoskeleton™ TCS Interbody

System.

▪ The Endoskeleton™ TCS 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™ TCS Interbody System, 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 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 devices 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. Thread 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, 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.