Medtronic 981315555 Instructions for Use

Catalyft™ LS Expandable Interbody

M333023W224E Rev. A

System

2021-12-13

IMPORTANT INFORMATION ON THE CATALYFT™ LS EXPANDABLE INTERBODY
SYSTEM

PURPOSE

This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following
surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in
the implant's material and surgical aspects and instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The Catalyft™ LS Expandable Interbody System is an expandable titanium alloy interbody device consisting of expandable
interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be
inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion
surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

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

INDICATIONS

The Catalyft™ LS Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature
patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by
patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™
LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal
deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel
degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used.
These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants
are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach.
The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with

supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended
to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional
supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are
intended to be used with 4 screws and supplemental fixation.

CONTRAINDICATIONS

The Catalyft™ LS Expandable Interbody System is not intended for cervical or thoracic spine use. Contraindications include:

▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital

abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation
of white blood count (WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented allergy or intolerance to composite materials.
▪ Cases not needing a fusion.
▪ Cases not described in the indications.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem.
▪ Pediatric cases, nor where the patient still has general skeletal growth.

▪ Translational instability (spondylolisthesis of any grade or retrolisthesis) at the levels treated unless posterior supplemental

fixation is used to augment stability.

▪ Cases where posterior elements were removed such that it introduces instability at the level(s) treated unless posterior

supplemental fixation is used to augment stability.

▪ Cases where implant components selected for use would be too large or too small to achieve a successful result.
▪ Cases requiring the mixing of metals from two different components or systems.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Prior fusion at the level to be treated.

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.

Take into consideration that the segmental stability can be affected by a variety of factors.

POTENTIAL ADVERSE EVENTS

Adverse effects may occur when the device is used either with or without associated instrumentation. Risk of adverse effects as
a result of movement and non-stabilization may increase in cases where associated complementary support is not employed.
Potential adverse events include:

▪ Implant migration.
▪ Breakage of devices.
▪ Foreign body reaction to implants including possible tumor formation, auto immune disease, and/or scarring.
▪ Pressure on surrounding tissues or organs.
▪ Loss of proper spinal curvature, correction, height, and/or reduction.
▪ Infection.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (pseudoarthrosis).
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain.
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of

serious injury.

▪ Cerebral spinal fluid leakage.
▪ Hemorrhage of blood vessels and/or hematomas.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
▪ Bone graft donor site complication.
▪ Inability to resume activities of normal daily living.
▪ Early or late loosening or movement of devices.
▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration and/or retropulsion of any spinal bone (including the sacrum,

pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Loss of or increase in spinal mobility or function.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Death.

Note: additional surgery might become necessary to correct adverse effects.

WARNINGS AND PRECAUTIONS

A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise results. Use of this product without autogenous bone graft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone or in cases that do not develop a union will not be successful.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and correct selection and
placement of implants are important considerations in successful use of the system. Further, proper selection and compliance of
patients greatly affect results. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients
should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/drug abuse patients and
those with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spinal fusion.

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal surgery.