Medtronic SPS03049 Instructions for Use

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.