Search Results

The CD HORIZON™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON™ Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD HORIZON™ LEGACY™ 3.5mm rods and the CD HORIZON™ Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (1.2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD HORIZON™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON™M System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The subject CD HORIZON™ Spinal System consists of non-sterile domino connectors, made of Titanium Alloy, that are used to provide the surgeon with an efficient construct extension as well as connection options for multi-rod spinal constructs. The subject CD HORIZON™ Spinal System includes 1. Non-sterile Domino connectors 2. Trays and lid

The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. The CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK).

The CD Horizon™ System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ LEGACY™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ System titanium, cobalt chrome, and stainless steel implants are 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, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ PEEK Rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The subject CD Horizon™ Spinal System is a multiple component device to allow the surgeon to build an implant system to fit the patients' anatomical and physiological requirements. The subject CD Horizon PEEK Rods consist of polyetheretherketone (PEEK) rods, multi-axial bone screws (MAS) and set screws to create a variety of semirigid configurations. The purpose of this traditional 510(k) is to modify the indications for the CD Horizon™ Spinal System.

When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System 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, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System 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. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer® Dynesys® Spinal System, including the Dynesys® Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers and polyethylene terephthalate (PET) cords. The Dynesys® pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with hydroxyapatite (HA). The Dynesys® Spinal System is also cleared for connection with the Zimmer® DTO™ implant. The Zimmer® DTO™ implant allows the connection of the Dynesys® Spinal System to the OPTIMA™ZS Spinal System when the two systems are used on contiguous levels.

When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System 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 and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Dynesys system 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. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO Implant, rodcord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Pin press has been designed to be part of the Zimmer DTO Instruments. The Zimmer DTO Implant is provided partially assembled, in that the cord is placed in the connecting part and fixed with a needle during the manufacturing process; the mechanical integrity of the cord/rod connection is achieved immediately prior to implantation by fully inserting a pin to compress the cord with an intra-operative instrument, this step is performed with the Zimmer DTO Pin press.

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 is intended to be used with autograft and/or allograft. 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 -- Rigid 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). This submission presents the addition of a 20mm long rigid coupler.

When used as a pedicle screw fixation system in skeletally mature patients, the Dynesvs Spinal System is intended to provide immobilization 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 spondy|olisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System 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. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer® Dynesys® Spinal System, including the Dynesys Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers, and polyethylene terephthalate (PET) cords. The Dynesys pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with ceramic hydroxyapatite (HA). The Dynesys Spinal System is also cleared for connection with the Zimmer DTO implant. The Zimmer DTO implant allows the connection of the Dynesys Spinal System to the Optima ZS Spinal System when the two systems are used on contiguous levels.

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 TRANSITION™ Stabilization System 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 in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, the TRANSITION™ Stabilization System 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; and who are having the device removed after the development of a solid fusion mass. TRANSITION™ is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

The TRANSITION™ Stabilization System implants include pedicle screws and implant assemblies which are provided pre-assembled or can be assembled intraoperatively. TRANSITION™ pedicle screws are coated with hydroxyapatite (HA). Either TRANSITION™ HA coated pedicle screws or specified REVERE® pedicle screws may be used in conjunction with the implant assemblies. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and larger, may be used with the TRANSITION™ implant assemblies. Implant assemblies consist of a polyethylene terepthalate (PET) cord, polycarbonate urethane (PCU) spacers and bumpers, and titanium alloy spools, end spools and set screw ends. The cord passes through the entire implant such that the spools are positioned to sit within the screw heads and the spacer sits between the spools. The end spool includes one end of the secured cord. The bumper followed by a set screw end is positioned at the other end of the cord. Implant assemblies are available in single or multi-level configurations. REVERE® locking caps with inner set screws are used to rigidly connect the pedicle screws to the implant assemblies. TRANSITION™ implants are available in a variety of sizes to accommodate varied patient anatomy. TRANSITION™ implants are manufactured from titanium alloy Ti6AI4V (ASTM F136) or Ti6Al7Nb (ASTM F1295), polyethylene terepthalate (PET), and/or polycarbonate urethane (PCU). Titanium alloy TRANSITION™ screws are hydroxyapatite (HA) coated (ASTM F1185).

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).