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The Jazz Claw System (hooks and rods) and the Jazz Frame System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) and the Jazz Frame System are intended for posterior fixation 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, spinal deformities (i.e., scoliosis and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt. The Jazz Claw System (hooks and rods) and the Jazz Frame System are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The JAZZ Frame spinal implants are spinal fixation devices consisting of the following components: T-bars, straight rods, connectors, and surgical instruments. The T-bars are fixed closed transverse connectors. The rods have been previously cleared as part of the ISS system and are used with the JAZZ Frame. The JAZZ Connector and JAZZ Braid have been previously cleared and are also used with the JAZZ Frame. There is no change to the previously cleared JAZZ instruments. Once the fusion rods have been bent to the desired shape, a T-bar is positioned at the top and middle of the two bars, and then tightened in place using the screwdriver. The caudal parts of the rods are inserted into heads of pedicle screws that have been previously implanted. The cranial end of the construct is then secured with JAZZ Connectors, and the screws of the T-bars undergo final tightening.

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - 1 Spinal trauma surgery, used in sublaminar or facet wiring techniques; - 2 Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis; - 3 Spinal degenerative surgery, as an adjunct to spinal fusions. The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants. The JAZZ System is intended to be used with the Implanet Spine System.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5. The modified JAZZ System is designed to function in the same manner as the cleared predicate device. The JAZZ System is intended to be used with the Implanet Spine System (K143731).

The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation 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 deformities (i.e., scoliosis, kyphosis and/or lordlosis), tumor, pseudarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The IMPLANET Spine System is a posterior instrumentation system. The polvaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm. The monoaxial pedicle screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3 and are available in 5.0 mm. 7.0 mm. and 8.0 mm diameters. The screws range in length from 35 to 60 mm. The system includes both straight and pre-bent rods made of Ti6AI4V titanium alloy. The transverse connectors are composed of Ti6AI4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods. The hooks are made of Ti6Al4V titanium alloy and are provided in multiple configurations. The purpose of this 510(k) is to extend the ISS line to include: - New monoaxial and polyaxial screws . - Cobalt Chromium rods - New Ti6Al4V titanium alloy rods ● - Offset connector and associated offset connector screws - Rod to rod connectors - . New instruments The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed. The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods. The purpose of the subject 510(k) notice is for a line extension to incorporate additional device dimensions and Cobalt Chromium rods, as well as compatible additional instruments, to the company's cleared system.

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques; - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis; - Spinal degenerative surgery, as an adjunct to spinal fusions. The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants. The JAZZ System is intended to be used with the Implanet Spine System.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5. The modified Jazz System is designed to function in the same manner as the cleared predicate device.

The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation 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, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm. The monoaxial pedicle screws are made of Ti6A!4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm. The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy. The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods. The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations. The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed. The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods. The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.

The Jazz System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2. spinal deformities such as scoliosis, kyphosis, spondylolisthesis; - 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The Jazz System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants. The JAZZ system is intended to be used with the CALYPSO pedicle screw system.

The device consists of the following components and accessories: polyester (polyethyleneterephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle.