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The Iatrical Lumbar Interbody Fusion Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Iatrical Lumbar Interbody Fusion Systems are intended for use in interbody fusions at the thoracolumbar junction (T12-L1), and are intended for use in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Iatrical Lumbar Interbody Fusion Systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The IatricalLumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine. The Iatrical Lumbar Interbody Fusion Systems (LLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. They may be implanted bilaterally using an anterior (ALIF) approach, a lateral (LLF) approach, or as a single device employing a transformational (TLIF) approach.

3D printing technology is used in the manufacture of Iatrical Lumbar Interbody Fusion Systems using titanium alloy. The devices have large central graft windows which can be used with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation

Iatrical Lumbar Interbody Fusion Systems are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.

Iatrical Lumbar Interbody Fusion Systems are delivered in a sterile condition and can be used without any further preparations. The devices are packaged in accordance with ISO 11607.

The provided text describes a 510(k) premarket notification for the "Iatrical Interbody Lumbar Fusion Systems." This submission is for a physical medical device (intervertebral body fusion system) and not for an AI/ML powered software or diagnostic device. Therefore, the information requested regarding acceptance criteria, study details, human reader performance, ground truth, and training set is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and performance data from mechanical testing. The performance data listed (e.g., Static Compression per ASTM F2077) are engineering tests for the physical device, not clinical or algorithmic performance metrics.

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