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The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations. The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).

The Arthrex Spine Compression FT Screws are headless, threaded, cannulated titanium implants that are available in a variety of sizes. The screws have a fully threaded screw shaft with a tapering head and a variable-stepped thread pitch that allows the screw the ability to provide compression and stability between bony fragments or joints.

The Karma® Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.

The Karma® Fixation System is a system that provides adjunctive fixation. The system consists of a PEEK band. The Karma band consists of a strap manufactured from PEEK compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip of the device contains a tantalum insert for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taut by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the bony structures. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. An instrument, Tensioner, is provided and can be used fully tension the implant.

The AERO MIS Facet Fusion System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: - Spondylolisthesis, - Spondylolysis, - Pseudoarthrosis or failed previous fusions which are symptomatic, or - Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability. The system is intended for use with bone graft material.

The AERO MIS Facet Fusion System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.

The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: - · Spondylolisthesis - · Spondvlolysis - · Pseudoarthrosis or failed previous fusions which are symptomatic · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136. The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.

The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients. The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.

The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively. The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation. The purpose of this 510(k) was to add a new screw size to the previously cleared zLOCK Lumbar Facet Fixation System (K240085) and to modify the length of the spacer component.

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 Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: - · Spondylolisthesis - · Spondylolysis - · Pseudoarthrosis or failed previous fusions which are symptomatic · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows, for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.

SC Medica FFX is a lumbar facet device that is placed bilaterally through a posterior surgical approach and spans the facet interspace. SC Medica FFX must be used with an FDA-cleared transfacet screw cleared for use in the lumbar spine. SC Medica FFX is intended to provide temporary fixation to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. SC Medica FFX must be accompanied with an FDA-cleared intervertebral body fusion device and/or with an FDA-cleared posterior lumbar pedicle screw and rod system implanted at the same spinal level(s) as an adjunct to a single or two-level intervertebral body or posterolateral fusion, respectively. SC Medica FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care.

FFX implants are intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints. The FFX implant is a sterile, single patient use, long-term implantable device made of titanium.

The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients. The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.

The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively. The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation.