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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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The Nu Vasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The Modulus ALIF System 10° 20° lordotic cages may be used as a standalone system. The Modulus ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft 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 SI, 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 radiographic studies. 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 spondylolisthesis 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 the FDA for use in the lumbar spine in addition to the integrated screws.

The subject NuVasive Modulus ALIF System are interbody implants manufactured from titanium alloy (Ti-6AI-4V ELI) powder conforming to ASTM F3001. 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. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The purpose of this submission is to introduce a non-sterile option of the Modulus ALIF bolts.

The provided text is a 510(k) summary for the NuVasive® Modulus® ALIF System. This document describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The relevant sections state:

• "The purpose of this submission is to introduce a non-sterile option of the Modulus ALIF bolt."
• "No new implant designs are being introduced, therefore no performance testing was performed for this 510(k) submission and the worst-case devices included with the subject system were tested and cleared in predicate 510(k) submissions."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this document does not describe such a study for an AI/ML powered device. The submission is for a material change (non-sterile option for a bolt) to an existing, cleared intervertebral body fusion device.

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