Medtronic 2140002 Instructions for Use

Pivox™ Oblique Lateral Spinal

M708348B494E Rev. C

System

2019-03-07

IMPORTANT INFORMATION ON THE PIVOX™ OBLIQUE LATERAL SPINAL SYSTEM

PURPOSE

The Pivox™ Oblique Lateral Spinal System consists of fusion devices (interbody cages) intended to stabilize and promote bone
fusion during the normal healing process following surgical correction of disorders of the spine and temporary implants (plates
and bone screws) intended for anterior column screw fixation. The product should be implanted only by a physician thoroughly
knowledgeable in the implant's material and surgical aspects and who has been instructed as to its mechanical and material
applications and limitations.

The Pivox™ Oblique Lateral Spinal System is intended for in vivo use, to provide stabilization and to promote bone fusion
between two adjacent lumbar vertebral bodies, and is to be used with autogenous bone graft and/or allograft material, or
Infuse™ Bone Graft (as designated below with the Pivox™ Oblique Lateral Spinal System Interbody Cage) to facilitate fusion.

DESCRIPTION

The Pivox™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.
The Pivox™ Oblique Lateral Spinal System interbody cages are available in various widths, heights, and lordosis inserted

between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow
geometry of the implants allows them to be packed with autogenous bone graft and/or allograft, or Infuse™ Bone Graft (as
designated below) and must be used with supplemental fixation. The cages are manufactured from medical grade
polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

The Pivox™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior
column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine.
Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique
approach. The Pivox™ Oblique Lateral Spinal System plate and bone screws are made from titanium alloy and are provided
sterile.

Medical grade titanium and medical grade PEEK may be used together. Never use titanium or titanium alloy implants with
stainless steel in the same construct.

No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.

INDICATIONS

The Pivox™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with
supplemental fixation systems cleared for use in the lumbar spine. The Pivox™ Oblique Lateral Spinal System interbody cage is
used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients
may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain
with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Pivox™ Oblique Lateral Spinal
System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to
pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These
implants may be implanted via a minimally invasive or open lateral or oblique approach.

Certain sizes of the Pivox™ Oblique Lateral Spinal System Interbody Cage may also be used with Infuse™ Bone Graft for
patients diagnosed with DDD, as defined above, who are skeletally mature and have had six months of non-operative treatment.
The device may be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L2- L5 and is
intended for use with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the Infuse™
Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the Pivox™ Oblique Lateral Spinal
System Interbody Cage approved for use with Infuse™ Bone Graft, as well as specific information regarding contraindications,
warnings, and precautions associated with Infuse™ Bone Graft. Infuse™ Bone Graft is not indicated for use in a direct lateral
interbody fusion (DLIF) surgical approach.

Additionally, the Pivox™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed
with degenerative scoliosis as an adjunct to pedicle screw fixation.These patients should be skeletally mature and have had six

months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique
approach. Infuse™ Bone Graft is not indicated for use in patients with this condition.

The Pivox™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device
for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the
bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be
understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the
anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin
with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4)
deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

When used together, the Pivox™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or
two contiguous levels from L2 to S1 (except as defined for use with Infuse™ Bone Graft above). These DDD patients may also
have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

CONTRAINDICATIONS

The Pivox™ Oblique Lateral Spinal System is not intended for posterior surgical implantation. Contraindications include, but are
not limited to:

▪ Any case needing to mix metals from different components.
▪ Any case not described in the indications.
▪ Any medical or surgical condition which would preclude the benefit of spinal implant surgery, such as the presence of

tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood
count (WBC), or a marked left shift in the WBC differential count.

▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone

quality, or anatomical definition.

▪ Any patient unwilling to cooperate with postoperative instructions.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ For interbody cage, patients with known hereditary or acquired bone friability or calcification problems.
▪ For interbody cage, prior fusion at the level to be treated.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Suspected or documented allergy or intolerance to the component materials.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.

Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:

▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.

Warning: this plate device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or
lumbar spine.

POTENTIAL ADVERSE EVENTS

All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible.
With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:

▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Change in mental status.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Disc disruption or degeneration at, above, or below the level of surgery.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Damage to the anterior vasculature.
▪ Damage to the peritoneum.
▪ Early or late loosening of the components and implant migration.
▪ For interbody cage, cauda equina syndrome.
▪ For plate device, atelectasis, ileus, gastritis.
▪ For plate device, dysphagia.
▪ For plate device, pressure on the skin from component parts in patients with inadequate tissue coverage over the implant

possibly causing skin penetration, irritation, and/or pain.

▪ For plate device, bursitis.