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The intended use of the Virata Spinal Fixation System in a posterior or anterolateral approach is 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 thoracic, lumbar, and sacral spine. The indications for use are as follows: - degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, - spondylolisthesis, - trauma (i.e., fracture or dislocation), - spinal stenosis, - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - spinal tumor, - pseudarthrosis, and/or - failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, the Virata Spinal Fixation System is also indicated as adjunct to fusion to treat: - Adolescent Idiopathic Scoliosis (AIS) - Neuromuscular scoliosis - Congenital scoliosis The Virata Spinal Fixation System can be used with components of the Mariner and Malibu Systems such as rods and connectors. The Virata Spinal Fixation System is intended to be used with autograft or allograft. Virata Spinal Fixation Navigated Instruments: The Virata Spinal Fixation Navigated Instruments are intended to be used in the preparation and placement of Virata screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Virata Spinal Fixation System is a pedicle screw-based system that utilizes modular and preassembled screws. The modular screw shanks and the shanks of the preassembled screws are available in solid and cannulated configurations, in a variety of length and diameter size options. The rods are provided in a variety of lengths, diameters, and material options in both straight and pre-contoured configurations that can also be bent with instrumentation to more optimally accommodate the anatomy. The Virata Spinal Fixation System consists of single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Screws are placed in the pedicles of the vertebral body using a posterior approach. The construct is connected using rods to span across screws implanted at various levels. The construct is secured using a set screw tightened to a predetermined torque value which is threaded into the top of the screw to secure the rod. All modular tulips and the tulips of preassembled screws of the system are designed to accept a rod through the opening in the top of the tulip, except the closed polyaxial modular tulip and the tulip of closed preassembled screws for which the rod is passed through an opening on the side of the tulip. The Virata Spinal Fixation System implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Non-sterile instruments also include instrumentation compatible with navigation arrays to allow for navigated implant placement.

The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: - Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). - Spondylolisthesis - Trauma (i.e. fracture or dislocation). - Spinal Stenosis - Deformities or curvatures (i.e scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation™ S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical RIVA Posterior Fixation System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The Xenix Medical RIVA Posterior Fixation System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of polyaxial pedicle screws, as well as connecting spinal rods, connectors, crossbars, and a separate set screw locking element. The instruments included in the Xenix Medical RIVA Posterior Fixation System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level System 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 the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.

The Annex® 2 Adjacent Level System consists of a selection of non-sterile, single-use locking screws, adjacent level devices, and connectors for attachment to an existing pedicle spinal fixation construct to extend a rigid spinal construct. The Annex® 2 Adjacent Level System components are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing between existing screw and rod hardware. The implant components of this system are manufactured from titanium (ASTM F67)), titanium alloy (Ti-6Al-4V ELI (ASTM F136)), and cobalt-chromium (CoCr (ASTM F1537)).

The COLONNADE Posterior Screw Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Fenestrated screws are not intended for use with cement.

The COLONNADE Posterior Screw Fixation System pedicle screw is an internal fixation device for spinal surgery. Various forms and sizes of these implants are available so that constructions can be utilized to account for the unique pathology and anatomy of each patient. The subject pedicle screws and set screw of COLONNADE Posterior Screw Fixation System are manufactured from Ti-6Al-4V ELI as per ASTM F136, and are anodized The subject rods are manufactured from Ti-6Al-4V ELI as per ASTM F136 and Co-28Cr-6Mo as per ASTM F1537.

The Eminent Spine 3D Titanium Pedicle Screw System is designed to provide immobilization and stabilization to the thoracic, lumbar and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 or 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.

The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps, and cross connectors with lock screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to 600mm in various increments. The radius of curvature of the pre-contoured rods is 154mm throughout the entire series. Cannulated polyaxial screws are available in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm diameters and in lengths ranging from 40mm to 60mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods. All components are manufactured from Ti6Al4V ELI. The screw is made specifically from Ti6Al4V ELI per ASTM F3001 and the tulip, set cap, rod, and cross link systems are made specifically from Ti6Al4V ELI per ASTM F136. The devices are sold non-sterile.

The HC Biologics Osteopoint Spinal Fixation System is intended to provide immobilization 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 thoracic, lumbar and sacral spine: -Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), -Spondylolisthesis. - -Trauma (i.e., fracture or dislocation), -Spinal stenosis, - -Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). -Tumor, - -Pseudoarthrosis, and/or -Failed previous fusion

HC Biologics Osteopoint Spinal Fixation System is top-loading, multiple components, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.

The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients: - · Patients who may require serial magnetic resonance imaging; - · Patients with small stature: · Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events; - · Patients at risk for implant prominence following surgery; - · Patients with hyperkykyphotic spinal deformities; OR. · Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery. The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity. The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments. The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity. The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The VADER® Pedicle System: The VADER® Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis) and spinal instability due to infection, surgical debridement, or decompression. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery. VADER®one Pedicle System: The VADER ®one Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of: - Polyaxial cannulated, fenestrated pedicle screws, - Polyaxial, cannulated, pedicle screws, ● - Curved. straight. S-rods. J-rods. ● - Connectors . The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

The Primus Spinal Fixation System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The Spinal Elements Primus Spinal Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Primus or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Primus or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use. When used for posterior non-cervical pedicle screw fixation in pediative patients, the Primus and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye. These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Primus screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Spinal Elements' Primus Spinal Fixation System is comprised of a variety of screws, hooks, rods, and connectors that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws. Navigation instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The Tiger 2 System is a pedicle screw system intended to provide Immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deform-ities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impair-ment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degener-ation of the disc confirmed by history and radios), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.