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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

There is no mention of acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the CapSure® PS System, which focuses on demonstrating substantial equivalence to a predicate device through device description, intended use, and a comparison of mechanical testing (which found "no significant differences"). It does not detail specific performance metrics, clinical studies, or the methodologies typically associated with establishing acceptance criteria and proving their fulfillment.

Therefore, I cannot provide the requested information.

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