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The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

The CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.

1. CAVUX Facet Fixation System (CAVUX FFS): CAVUX Facet Fixation System (CAVUX FFS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. - CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. - CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. - CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. 2. CORUS-LX Implant: CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. CORUS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). CORUS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

CAVUX FFS and CORUS-LX Implant are posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX LevelOne is a kit that contains CORUS-LX Implant and accessories. The devices are placed through a posterior surgical approach and achieve facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. The devices are manufactured from medical grade titanium alloy (6Al4V) and supplied sterile for single use only with pre-attached disposable delivery instruments. The implants are fenestrated and to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

PMT Posterior Cervical Stabilization System (PCSS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. PMT PCSS is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s). PMT PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. PMT PCSS is to be used with autogenous bone and/or allogenic bone graft.

PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. The device is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. The device is manufactured from medical grade titanium alloy (6A14V) and supplied sterile for single use only with a pre-attached disposable delivery instruments. The implant is fenestrated and is to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. CORUS® Spinal System is used to access and prepare the site for posterior fusion.

The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically 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 long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. PMT FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level (s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). PMT FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is composed of CAVUX® Cages and ALLY® Bone Screws, an integrated construct, manufactured from medical grade titanium alloy and supplied sterile for single use only with a pre-attached disposable delivery handle/inserter. PMT FFS-LX provides temporary stabilization by spanning the facet interspace with points of fixation at each end of the construct and provides fixation as an adjunct to fusion. An ALLY Bone Screw is intended to be utilized to provide additional anchoring. CAVUX Cages are offered in a variety of sizes to accommodate various patient anatomies and pathology. The cage is designed to be filled with bone graft to permit formation of new bone through the device. ALLY Bone Screws are fully threaded. CORUS™ Spinal System is recommended to access the site and perform posterior fusion.

PMT Expandable Cage (PMT EXP) is an integrated construct comprised of a CAVUX Cage-E and a single ALLY Screw-E. PMT EXP is placed bilaterally through a posterior surgical and spans the facet interspace with points of fixation at each end of the construct. PMT EXP is intended for temporary stabilization as an adjunct to single level posterior cervical fusion in skeletally mature patients. PMT EXP is only intended for use with a single level anterior cervical fusion at the same spinal level that utilizes FDA cleared/approved spine stabilization hardware for anterior cervical fusion procedures. PMT EXP is indicated for the treatment of patients with cervical degenerative disc disease (DDD) with radiculopathy from C3-C7. PMT EXP is indicated for use with autogenous and/or allogenic bone graft.

The PMT Expandable Cage (PMT EXP) is comprised of a CAVUX Cage-E and an ALLY Expansion Screw as an integrated construct, manufactured from medical grade titanium alloy, and supplied sterile for single use only. The components are provided with a pre-attached disposable delivery handle/inserter. The device achieves facet fixation by spanning the interspace with points of fixation at each end of the construct and provides temporary, bilateral, rigid fixation as an adjunct to fusion. CORUS® Spinal System is recommended to access the site and perform posterior cervical fusion. The threads of the Expansion Screw interface with the slot features of the Cage-E to increase the height of the Cage-E and promote strength of the total construct. The profile of the Cage-E provides contact area between the device and adjacent bony surfaces to fixate the segment. The Expansion Screw is made of 6AL 4V ELI Titanium (ASTM F136) and the washer is made of Commercially Pure Titanium Grade 2 (ASTM F67).

PMT Facet Fixation System (PMT FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. PMT FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. PMT FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. PMT FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

The PMT Facet Fixation System (PMT FFS) is composed of CAVUX Cages and ALLY Bone Screws as an integrated construct with both manufactured from medical grade titanium alloy 6AI4V—ELI Ti (ASTM F136) and supplied sterile for single use only. The components are provided with a pre-attached disposable delivery handle/inserter. PMT FFS achieves facet fixation by spaming the interspace with points of fixation at each end of the construct and provides bilateral rigid fixation as an adjunct to fusion with ALLY Bone Screws providing additional anchoring. CAVUX Cages are fusion devices offered in a variety of sizes to accommodate various patient anatomies and pathology. The center of the cage is hollow and designed to be filled with bone graft into the "windows" to permit formation of new bone through the cage. The ALLY Bone Screw is fully threaded. CORUS® Spinal System is recommended to access the site and perform posterior cervical fusion.

For Cervical Fusion: CORUSTM System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease. For Lumbar Fusion: CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

The CORUS™ Spinal System-X is a set of instruments indicated for performing posterior cervical or lumbar fusion. The instruments will be supplied sterile and single use only. The system consists of: - Access Chisel - Access Chisel Handle - Trephine Decorticator - Guide Tube - Rasp Decorticator - Rotary Decorticator - Bone Graft Tamp - Multi-Tool - Guide Tube Adapter These instruments allow the user to access the posterior cervical or lumbar spine to perform posterior fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.

The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following: 1. Pseudoarthrosis and failed previous fusion 2. Spondylolisthesis 3. Spondylolysis 4. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies 5. Degeneration of the facets with instability; and 6. Fracture The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

The PMT Facet Screw is available in fully threaded configurations with diameters of 3.5 mm, 3.75 mm and 4.0 mm and lengths of 13 mm to 25 mm (in 2 mm increments). The PMT Facet Screw is constructed of Titanium-6 Aluminum- 4 Vanadium ELI alloy (conforming to ASTM F136-13) and supplied sterile for single use only.

CORUS Spinal System is a set of instruments to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

The CORUS™ Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of Access Chisel, Access Chisel Handle, Decortication Trephine, Guide Tube, Decortication Rasp, Decortication Burr, Bone Graft Tamp and a Fork Mallet. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.