AccelFix Spinal Fixation System

The AccelFix Spinal Fixation System is a posterior thoracolumbar, sacral, and iliac fixation system designed for spinal immobilization and stabilization in skeletal mature patients. It is indicated as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, deformities, tumors, stenosis, and failed previous fusion.

The system comprises pedicle screws, rods, hooks, cross-links, connectors, and instruments designed to accommodate varying patient anatomy. It offers multiple implant configurations including monoaxial and polyaxial options, reduction capability, specialty screw options, and modular design allowing customized construct assembly. Components are made of titanium alloy and biocompatible metallic materials with threaded implant features to enhance bone fixation.

ASTM F1717 was cited as the standard test method for spinal implant constructs. Mechanical bench testing of the predicate devices was conducted in accordance with this standard.

The subject device is substantially equivalent to the predicate AccelFix devices (K232311 and K182544) because they share the same design, materials, scientific technology, and indications for use. Engineering analysis demonstrated that design modifications do not represent a worse-case condition relative to the predicate, and mechanical performance testing showed substantially equivalent performance to the predicate devices.