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The VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture;
• instability associated with correction of cervical lordosis and kyphosis deformity;
• instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The VyPlate™ Anterior Cervical Plate System is comprised of implant, instrument, and tray components. The implant components, the VyPlate™ device, consists of anterior cervical plates with integrated cover plates and bone screws. The implant components of the VyPlate™ Anterior Cervical Plate System are composed of Titanium alloy 6Al-4V as described in ASTM F-136.

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The ANTERIS Thoracolumbar Plate System Plates are intended for use 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 the anterior surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Trauma (i.e. fractures, including dislocation and subluxation), tumors, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, deformities (i.e. scoliosis, kyphosis, or lordosis), spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The ANTERIS Thoracolumbar Plate System is an anterior, anterolateral, or lateral plate fixation system intended for use in the thoracic, lumbar, and sacral spine (T1-S1). The plates are pre-contoured to accommodate anatomical alignment and incorporate a central vertical slot to facilitate visualization and graft placement. The ANTERIS plates are offered in standard and optional large versions. Screw back-out is prevented through the use of anti-backout caps. The system is intended to provide temporary stabilization and support to promote the development of a solid spinal fusion.

The ANTERIS Thoracolumbar Plate System consists of plates and bone screws made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

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The PathLoc Lumbar Plate System is indicated for use via the anterior surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion.

This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

The system consists of plates and fixation screws manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136 standards, and it includes manual surgical instruments commonly used in general surgical procedures.

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The ASTER is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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 failed previous fusion.

The ASTER is an anterior cervical plate system made from titanium alloy in accordance with ASTM F136. The system consists of various plates and screws, and fixation is achieved by inserting bone screws through the plate openings into the cervical vertebral bodies. Each plate includes locking caps designed to prevent screw back-out, and the locking caps are provided pre-assembled to the plate.

A variety of plate lengths and screw configurations are available to accommodate patient anatomy. The product is supplied only in a non-sterile condition, and must be steam sterilized prior to use.

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The Lumbar Spine Truss System Plating Solution (LSTS-PS) non-integrated plate is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral, anterolateral, or anterior lumbar (L1-S1) 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The LSTS-PS integrated plate may be attached and remain attached to a Lateral Spine Truss System (LSTS) Interbody Fusion Device or an Anterior Spine Truss System (ASTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS integrated plate is intended to be used with supplemental fixation (e.g. posterior fixation).

The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the screw. The plates are available in 1-hole, 2-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy.

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The Sync Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Sync VBR Fusion System is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The Sync Cervical Interbody Fusion System is an anterior interbody fusion device for use in the cervical spine (C2-T1). The Sync VBR Fusion System is a vertebral body replacement device for use in the cervical and thoracic spine. Interbody and VBR Fusion components are available in a variety of heights and footprints to suit the individual pathology and anatomy of the patient. The device components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or PEEK conforming to ASTM F2026. The PEEK interbody fusion device components have tantalum marker pins manufactured from tantalum per ASTM F560 for radiographic visualization.

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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, kyphosis, 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 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for 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, CD Horizon™ Spinal 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™ Spinal 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 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 (L2 – S1) in skeletally mature patients. Devices are 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, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, 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 Vertex™ indications for use.

The CD Horizon™ LigaMAS Head Assembly used with the LigaPASS™ Spinal 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, used in sublaminar, or facet wiring techniques
• Spinal reconstruction surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis;
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non-pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples, and washers, GDLH™ rods, hooks, connectors, and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws.

Note: certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

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The VyBrate-L™ VBR System is intended for use in the thoracolumbar spine (T1‐L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VyBrate-L™ VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

The VyBrate-C™ VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The VyBrate-C™ VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VyBrate-C™ VBR System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Vy Spine™ VyBrate™ VBR System is comprised of implants components. The implant component, the VyBrate™ VBR device, is a spacer, which inserts between vertebral bodies in the anterior column of the thoracolumbar or cervical spine. The spacer is made of OXPEKK with Tantalum markers.

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The aprevo® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications:

• Degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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
• Failed previous fusion.

The aprevo® cervical plating system, which is comprised of the aprevo® cervical segmental plating system and the aprevo® cervical multilevel plating system configurations, is intended for anterior fixation of the cervical spine. The system consists of a variety of segmental and multilevel plates that are additively manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F3001 as well as a range of fixation screws manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F136. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the implants, are manufactured from stainless steel per ASTM A564. The plates, screws, and instruments are provided sterile packaged for single patient use.

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EFFORTMED CERVICAL PEEK CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. CERVICAL PEEK CAGES facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autograft/autologous bone graft. Patients should have received at least six (6) months of prior non-operative treatment. EFFORTMED CERVICAL PEEK CAGES are to be used with supplemental fixation.

The EFFORTMED LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.

The EFFORTMED ORIZABA CERVICAL CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The EFFORTMED COTOPAXI LUMBAR CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The ORIZABA and COTOPAXI CORPECTOMY CAGES are also 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 cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

ORIZABA and COTOPAXI CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

The EffortMed spinal interbody cage system includes cervical intervertebral body fusion (IBFD), transforaminal lumbar interbody fusion (TLIF), and posterior lateral interbody fusion (PLIF) devices. The cervical cage models are the EffortMed Pacaya Cervical PEEK Cage and Masaya Augmented Cervical PEEK cage. The lumbar cage models are the EffortMed TLIF PEEK Cage, Effortmed TLIF PEEK Cage 4° Angled, Effortmed PLIF PEEK Cage, EffortMed PLIF PEEK Cage 5° Angled, and EffortMed Expandable PLIF PEEK Cage. The system was designed to restore height and lordotic angle in the spine. The main role of the cages is to help maintain the cleared disc space stable and intact, until a healthy bony fusion occurs between the adjoining vertebrae. To help achieve this, the inner chamber of the cage body is filled with bone graft before implantation.

The system also includes cervical and corpectomy cages (identified as used in cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to, tumors, fractures, and infections. The corpectomy cage models are the EffortMed Orizaba Cervical Corpectomy cage and EffortMed Cotopaxi Lumbar Corpectomy cage.

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