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The coflex-IF is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The coflex-IF system is an implant system for interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes. The purpose of this Special 510(k) is to add a notch in the posterior portion of the U-shaped body. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The DSS™ Stabilization System - Rigid is intended for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft. Note: The Rigid Couplers are for single-level use only. The traditional straight rods are for single- and multi-level use. The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients: - Who are receiving fusions with autogenous graft only; - Who are having the device fixed or attached to the lumbar or sacral spine; - Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSSTM Stabilization System is comprised of a variety of pedicle screw sizes, couplers, and straight rods that act as longitudinal components that are uniquely fitted for each individual case. The pedicle screws, couplers, and straight rods are manufactured from medical grade titanium alloy (Ti6Al4V). The purpose of this 510(k) is to add multi-level use for the traditional straight rod components of the DSSTM Stabilization System - Rigid.

The coflex-F Implant System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The coflex-F Implant System is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, Ushaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes. The purpose of this Special 510(k) is to add small- and medium-sized coflex-F Short devices to the coflex-F Implant System. The modifications are intended to allow the operating surgeon to better accommodate various patient anatomies. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

DSSTM Stabilization System - Rigid The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft. DSSTM Stabilization System - Slotted The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients: - Who are receiving fusions with autogenous graft only; . - Who are having the device fixed or attached to the lumbar or sacral spine; . - . Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V). The purpose of this Special 510(k) is to add a straight rod, straight rod with pan, and polyaxial screw to the DSS Stabilization System - Rigid. The modifications are intended to allow the operating surgeon to better accommodate patient anatomies with more construct options. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The Paradigm Interspinous Fusion Plate is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6A14V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

DSSTM Stabilization System - Rigid: The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrac in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft. DSSTM Stabilization System - Slotted: The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients: Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; . Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6AI4V).

The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft. The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients: Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine: ● Who are having the device removed after the development of a solid . fusion mass." Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The subject systems are comprised of a variety of pedicle screws and Couplers that act as longitudinal spacers. The systems are intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The subject systems are fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136).

The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autograft and/or allograft.

This 510(k) adds additional screw sizes to the DSS™ Stabilization System. The DSSTM Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V).

The DSSTM Stabilization System - Rigid Coupler is intended for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autografl and/or allograft. The DSS™ Stabilization System – Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back opin of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal sterensis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSS™ Stabilization System is comprised of a variety of pedicle screws and Rigid Couplers that act as longitudinal spacers. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The DSS™ Stabilization System consists of: - DSS™ pedicle screw sets . - DSS™ Rigid Couplers . The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V (ISO 5832-3 and ASTM F136).