Reform Pedicle Screw System

The Reform Pedicle Screw System is a posterior spinal fixation device consisting of pedicle screws, rods, cross-connectors, and other modular components made from stainless steel, cobalt chromium, or titanium alloys. It provides immobilization and stabilization of the thoracic, lumbar, and sacral spine as an adjunct to fusion in skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumors, pseudarthrosis, and failed prior fusion. The fenestrated variant allows injection of PMMA bone cement for temporary spinal integrity restoration in advanced tumor patients without fusion.

The subject device has nearly identical technological characteristics to predicates, including the same indications for use, structural support mechanism, materials (ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136, ISO 5832-3), sterility, sizes, and biocompatibility. The only difference is fenestration diameter and quantity at the screw tip, which do not raise new safety or efficacy concerns because bone cement injection testing demonstrated successful cement delivery through the fenestrations.

Dynamic Compression Bending per ASTM F1717 and bone cement injection testing. Materials conform to ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136, and ISO 5832-3.

The subject fenestrated screws share all essential technological characteristics with three predicates (G21 Cement/Vader system, CD Horizon Fenestrated Screw, and the previously-cleared Reform system). The minor design differences—fenestration diameter and configuration—do not create new safety or effectiveness questions because dedicated bone cement injection testing on the subject fenestrated screws confirmed successful cement delivery. The mechanical performance (dynamic compression bending) remains equivalent to predicates, and the intended use, materials, manufacturing, and biocompatibility are identical.