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When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw.

The Lateral Plate System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• -Spondylolisthesis

• -Spinal stenosis

• -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)

• -Tumor

• -Pseudoarthrosis

• -Failed previous fusion

• -Trauma (i.e., fracture or dislocation)

The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.

The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer System components should never be reused under any circumstances.

The Lateral Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

The Lateral Plate System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

Do not use any of the Lateral Plate System components from any other system or manufacturer. The Lateral Plate System components should never be reused under any circumstances.

This document is an FDA 510(k) summary for a medical device (TruLift® Lateral Expandable Spacer System & Lateral Plate System). It describes the device, its intended use, and its equivalence to predicate devices, focusing on design, materials, and mechanical performance. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or AI-specific study details (such as MRMC studies or standalone algorithm performance), as these types of studies are not relevant to the content provided in this 510(k) summary. This document is focused on demonstrating the physical and mechanical equivalence of the spinal implant system to existing predicate devices, not on the performance of a software or AI component.

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