Genesys Spine TiLock Modular Spinal System

Vendor/Manufacturer: Genesys Spine

Product/Product Line: TiLock Modular Spinal System

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3070

FDA Regulation Description Classification Name:

Pedicle Screw Spinal System

FDA Classification Product Code: NKB

FDA Classification Product Code Device Name:

Thoracolumbosacral Pedicle Screw System

SUBSTANTIALLY EQUIVALENT to the following products:

1. NuVasive MAS PLIF Fixation System

2. Genesys Spine TiLock2 Spinal System

3. Genesys Spine TiLock Pedicle Screw System

Device Description:

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.

Indications for Use:

The Genesys Spine TiLock Modular Spinal System is intended for the following indications:

The Genesys Spine TiLock Modular Spinal System is intended for posterior, noncervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion