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The Genesys Spine TiLock Modular Spinal System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the racic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, Genesys Spine TiLock Modular Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Genesys Spine TiLock Modular Spinal 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 Genesys Spine TiLock Modular Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Genesys Spine TiLock Modular Spinal System is also intended for the following indications: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Genesys Spine TiLock Modular Spinal System is a spinal system that consists of a variety screws, lock screws, rods and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The TiLock Modular Spinal System implants are manufactured from titanium alloy per ASTM F136 and F1472 and Cobalt Chrome per ASTM F1537.

The Genesys Spine TiLock Modular Spinal System is comprised of inter-changeable Tulip heads, polyaxial screws (solid and cannulated) in various lengths and diameters, lock screws, and rods in various lengths. The TiLock Modular cannulated polyaxial screws may be implanted via a conventional (open) technique or with an over-the-wire technique. Manual instrumentation for implantation of the system is available for both techniques. The over-the-wire procedure is performed using k-wires and fluoroscopy. The implantable components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537.

This document is about the FDA's 510(k) premarket notification for the Genesys Spine TiLock Modular Spinal System. It does not describe an AI/ML powered medical device, therefore the requested information cannot be extracted.

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