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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.

The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.

The Frida™ Anterior Cervical Plate System is an anterior cervical plating system that consists of single-use plates and screws, along with manual instruments for implant insertion. The plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and come in a variety of lengths to accommodate individual pathology and anatomical conditions of the patient. Plates incorporate a graft window for intraoperative visualization. Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and are available in self-tapping and self-drilling options. Screws are available in a fixed or variable configuration, with a range of sizes to accommodate individual pathology. Plates and screws are available in single-use sterile packaging.

X-PAC® N-GAGE™ 2-Hole and 4-Hole Lumbar Plate System is indicated for temporary stabilization during spinal fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients for the treatment of degenerative disc disease (DDD), spondylolisthesis, spondylolysis, spinal stenosis, pseudoarthrosis, deformity (defined as scoliosis, kyphosis, or lordosis), tumors, trauma (i.e. fractures including dislocation and subluxation), and/or failed previous fusion. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. N-GAGE™ 2-Hole and 4-Hole Plates may be assembled with the X-PAC® LLIF Expandable Cage to create a plate-spacer assembly. When assembled to the X-PAC® LLIF Expandable Cage, the plate-spacer assembly is indicated for standalone use at one or two levels of the lumbosacral spine (L2-S1), as an adjunct to fusion in skeletally mature patient with degenerative disc disease (DDD). DDD is defined as discogenic back pain 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(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have at least six (6) months of non-operative treatment. N-GAGE™ 1-Hole Plate is to be assembled with the X-PAC® LLIF Expandable Cages. When assembled, the system is intended to maintain the relative position of X-PAC® LLIF Expandable Cage and intended for use with supplemental fixation (e.g., posterior spinal systems).

X-PAC® N-GAGE™ Lumbar Plate System is a lumbar plate system comprised of implants (plates and screws), couplers, and surgical instruments. The implants are used in a lateral approach interbody fusion and are designed to provide rigid stabilization and support to the spinal column. The plate helps to restrict movement between adjacent vertebrae, preventing further injury and promoting the fusion of the bones over time. During operation, the plate is positioned laterally or anterolaterally, following insertion of a spinal interbody fusion spacer, via a removable inserter and screwdriver. The plate system can be installed either attached to (with a coupler) or floating from the X-PAC® LLIF Cage. The plates are available in multiple sizes and configurations to accommodate all heights of interbody spacing. The plates have a flat, elongated shape that conforms to the curvature of the spine at the required level(s) and have holes to secure the plate to the vertebrae. The fully threaded screws are available in two diameters and multiple lengths to accommodate varying anatomies. The screws are inserted into the vertebral body to hold the plate in place. The system includes a 1-hole, 2-hole, and 4-hole configuration. The screw can be angled up to 20 degrees away from the cage, and 10 degrees towards the cage. Each screw hole has an adjacent tab, which is turned and locked over the screw head once the screw has been inserted. The coupler is used to create a secure connection between the plate and the interbody device. The plates, screws, tabs, and couplers are manufactured from medical grade titanium alloy per ASTM F136.

The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level. The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers. The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.

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.

The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies) 2. Spondylolisthesis 3. Spinal stenosis 4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 5. Pseudoarthrosis 6. Revision of previous surgery

The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The device has a shape which restores the intervertebral height and lordosis. The Elegance® Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw's holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are self-drilling or self-tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance® plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy.

The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Deqenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions. When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

The Life Spine Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach. The Life Spine Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the components with components from any other system or manufacturer. The Cervical Plating System components should never be reused under any circumstances.

The Vertiwedge® Intraosseous System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement of a diseased or damaged vertebral body resected or excised to replace a portion and/or restore the height of a collapsed vertebral body for the treatment of previous trauma (i.e. fracture or tumor) or degenerative spine disease. The system is to be placed within the vertebral body following an osteotomy and supplemented with autograft or allograft and to be used with its contralateral staple; should a physician choose to use fewer than the maximum number of screws, then supplemental fixation must be used to augment stability. The Vertiwedge® Intraosseous System is intended to restore the integrity of the spinal column even in the absence of fusion in patients with advanced stage turnors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Vertiwedge® Intraosseous System is an intraosseous device that is used as a motion-preservation partial vertebral replacement device in the thoracolumbar spine in the motion-sparing Vertebral Body Osteotomy (VBO®) procedure. The Vertiwedge® Intraosseous device is used within a single osteotomized vertebral body, and it does not span any disc levels nor involve resection of or interference with the discs. The Vertiwedge® Intraosseous device is implanted through an anterior to psoas/oblique approach following an osteotomy of the vertebral body, in a Vertebral Body Osteotomy (VBO®) procedure The Vertiwedge® Intraosseous System consists of the intraosseous wedge (or spacer) with a lateral plate and a unique staple that provides integrated contralateral fixation. The Vertiwedge® Intraosseous System is available in a variety of heights and geometric options to accommodate variations in pathology and patient anatomy. Protrusions on the superior and inferior surfaces grip the osteotomized vedges to aid in expulsion resistance. The Vertiwedge® Intraosseous System is to be filled with autogenous bone graft and/or allogeneic bone graft material, and is to be used with the titanium alloy bone screws and cover plate to provide fixation within the single impacted vertebral body. All implant components are manufactured from Ti-6Al-4V ELI per ASTM F3001 or ASTM F136.