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The SPIRA®-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

When used with screws, SPIRA®-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA®-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

The SPIRA®-C Integrated Fixation System cages are interbody cages with integrated screws to provide additional fixation in interbody fusion procedures. The subject submission seeks to add anchors as an option for use for integrated fixation. The SPIRA-C® Integrated Fixation System cages are provided various heights and footprints to accommodate patient anatomy. The SPIRA®-C Integrated Fixation System has spiral supports to allow for a hollow chamber to permit packing with bone graft to facilitate fusion. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. When used with screws as integrated fixation, SPIRA-C Integrated Fixation is a stand-alone cervical fixation device. However, this submission seeks to add anchors as another option for integrated fixation. When used with anchors, the SPIRA-C Integrated Fixation System must be used with supplemental fixation.

This document is a 510(k) Summary for the SPIRA®-C Integrated Fixation System, a medical device. It does not describe a study involving an algorithm or AI. Therefore, it is impossible to extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for AI model development.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on engineering rationale. It states that "Testing, through the use of Finite Element Analysis (FEA) simulations, shows that the anchors are equivalent to the screw-based construct and has less internal stress than the non-integrated SPIRA® -C Open Matrix cage." This is the extent of the "performance testing" described.

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