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The Rexious Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is intended for use as a posterior, non-pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document is a 510(k) summary for the Rexious Spinal Fixation System. It explicitly states that no performance testing was required for this submission. The basis for clearance is that the device is identical to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be provided from the given text because such studies were not conducted for this specific submission.

The relevant section from the document is:

• Performance Data: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K100765, K113324, K111362, and K173131. No testing is required."

This means the device's acceptance was based on its substantial equivalence to a previously cleared device, not on new performance data demonstrating it meets specific acceptance criteria through a new study.

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