Anterior and lateral lumbar interbody device systems

Anteralign™ TL spinal system

<p>The Anteralign™ TL spinal system is a titanium interbody device designed to support lumbar spine fusion for degenerative and spinal deformity patients.</p>

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Indications, Safety, and WarningsAnteralign™ spinal system with Titan nanoLOCK™ surface technology system interbody cages with macro-, micro-, and nano- roughened surface textured features are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic 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 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device.Additionally, the Anteralign™ spinal system with Titan nanoLOCK™ surface technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Anteralign™ spinal system with Titan nanoLOCK™ surface technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof. These implants may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. The Anteralign™ spinal system must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine.Miniplate and bone screw components are provided as an option for anti-migration for the lumbosacral levels oblique or lateral above the bifurcation (L2-L5) of the vascular structures. Indications and contraindications of spinal instrumentation systems should be understood by the surgeon.This device is not intended for cervical spine use. Contraindications include:

Cases where there is translational instability (spondylolisthesis of any grade or retrolisthesis) at the level 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

Severe osteoporosis

Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality

Infection local to the operative site

Signs of local inflammation

Fever or leukocytosis

Morbid obesity

Pregnancy

Mental illness

Adverse effects may occur when the device is used either with or withoutassociated instrumentation. The 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 the device

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

Features

The Anteralign™ TL spinal system brings together smart design and proven technology to help surgeons deliver great outcomes.

nanoLOCK™ surface technology. Nano-textured surface designed to encourage bone attachment.
Honeycomb windows and large graft cavity. Maximizes space for bone graft and supports bone growth.
Flexible sizing. Multiple heights, widths, lengths, and lordosis options to fit patient anatomy.
Optional mini plate and bone screws. Added anti-migration support for peace of mind.
Navigation and robotic compatibility. Works with StealthStation™ and Mazor™ platforms for precise placement.
Sterile-packed, single-use implants. Ready for the OR, every time.

Anteralign™ TL spinal system helps streamline surgery with minimal instrumentation and flexible sizing. Its versatile design supports multiple surgical approaches, while advanced surface technology and honeycomb structure promote strong bone growth and reliable stability.

Anteralign™ TL spinal system

Features

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