Search Results

When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation, 4) scoliosis, 5) kyphosis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

The Procyon Spinal System consists of polyaxial screws, rods, and connecting components. The components are fabricated from titanium alloy (ASTM F-136).

This is a premarket notification for the Procyon Spinal System, a medical device, not an AI/ML device, and therefore does not contain information related to acceptance criteria, diagnostic performance, or studies with methodologies relevant to AI/ML. The provided text describes the device, its intended use, and indicates that "Performance data were submitted to characterize the Procyon Spinal System." However, the specific details of this performance data and any acceptance criteria are not included in the provided document snippet.

Therefore, I cannot provide the requested information.

Ask a specific question about this device