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KHEIRON® Spinal Fixation System including patient specific K-ROD is intended 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components that are only compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.5mm or larger and at least 25mm in length.

Patient specific K-ROD devices are compatible with Seaspine Mariner System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.5mm or larger and at least 25mm in length.

Patient specific K-ROD devices are compatible with Vital™ Spinal Fixation System components that are compatible with Ø5.5mm and/or Ø6.0mm rods as well as screws Ø4.0mm or larger and at least 20mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650, K251804) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is made from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Vital™ Spinal Fixation System is a 510(k) cleared pedicle screw system (K240539) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Vital™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Vital™ Spinal Fixation System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend S.M.A.I.O.'s patient specific K-ROD (K211981, K232650, K251804) for use with the Vital™ Spinal Fixation System (K240539).

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