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The CoreLink Midline Fixation System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic. lumbar, and sacral/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discoqenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink Midline Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink Midline Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The CoreLink Midline Fixation System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization of spinal segments. The system consists of polyaxial screws, extended tab reduction tulips, cross-link connectors, set screws, and spinal rods. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.

All screw shanks, set screws, and cross-connectors are manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The screw tulip heads which are modularly attached to the screw shafts by the surgeon during operation are manufactured from medical grade cobalt chrome (Co-28Cr-6Mo) per ASTM F1537, Ti-6Al-4V ELI per ASTM F136, and Nitinol per ASTM F2063. Once the polyaxial screws are affixed into the bone, immobilization and stabilization is achieved by connecting each spinal segment to a spinal rod. Rod components are manufactured from medical grade titanium alloy (Ti-6AL-4V ELI) per ASTM F136 or cobalt chrome (Co-28Cr-6Mo) per ASTM F1537.

This document is a 510(k) summary for the CoreLink Midline Fixation System, a medical device. It does not describe an AI/ML powered device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or MRMC studies for an AI device.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical performance testing, not through clinical trials or AI/ML performance evaluations.

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