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The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. These devices are intended to be used with bone screws, anchoring blades, or a combination of the two. When used with Modulus ALIF bone screws, the Modulus ALIF System 10° 20° lordotic cages may be used as a standalone system. When used with Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.q., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (e.g., radiographs, CT scan, MRI scan). The Modulus ALIF 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 spondylolistheses and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by FDA for use in the lumbar spine in addition to the integrated screws/anchoring blades.

The subject NuVasive Modulus ALIF System interbody implants are manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. When used with the Modulus ALIF bone screws, the Modulus ALIF Interfixated System 10°- 20° lordotic cages may be used as a standalone system. When used with the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25°- 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine.

The purpose of this submission is to introduce the Modulus ALIF anchoring blades (blades), which are a new in-line fixation option, provided sterile and non-sterile, for the NuVasive Modulus ALIF System.

The provided text is a 510(k) summary for the NuVasive Modulus ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, material composition, function, and range of sizes, supported by mechanical performance testing.

Therefore, it does not contain the specific information requested regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, or the results of a multi-reader multi-case (MRMC) study. The NuVasive Modulus ALIF System is an intervertebral body fusion device and is not an AI/ML powered medical device.

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