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The Ti-TaMED Spinal System is intended for immobilization and stabilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Ti-TaMED Spinal System consists of a variety of rods, hooks, screws, cross connectors and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The System consists of four types of screws all manufactured out of Titanium (6A 1-4V ELI). 1. Poly Axial Screws: These screws have a poly axial articulation that allows angulations of the head in all directions, but once the cap or grub screw and ring are tightened the position becomes locked. 2. Rigid screws. The Ti-TaMED Spinal system consists of two different types of rods: Round both ends and Round and hexagonal ends. The Ti-TaMED Spinal system also consists of the following: Cross Connector and Hooks. The Ti-TaMED screws and rods may be used posteriorly or anteriorly to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or lumbar spine. The Ti-TaMED spinal implant components can be rigidly locked into a variety of configurations, with each case being tailor made for the individual. The Ti-TaMED hooks and cross connectors are intended for posterior only, where as all other components may be used anteriorly or posteriorly.

This document is a 510(k) summary for the Ti-TaMED Spinal System, a spinal fixation device. It describes the device, its components, indications for use, and declares substantial equivalence to predicate devices. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than performance study results against specific acceptance criteria.

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