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The KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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.

The KLIMT Expandable LIF Cage System is a lumbar intervertebral fusion cage that is implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The subject cage is vertically expandable i.e., it has a height adjustable feature for ease of implantation and final secure fit to a patient's anatomy. The cage's components are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method) and assembled into a final cage unit. The cages are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and are provided both sterile and nonsterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

When used as an Intervertebral Body Fusion device, the RODIN Expandable Lumbar Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The RODIN Expandable Lumbar Cage System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA. When used as a Vertebral Body Replacement device, the RODIN Expandable Lumbar Caqe System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The RODIN Expandable Lumbar Cage System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA.

The RODIN Expandable Lumbar Cage System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, heights, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using CTL Medical instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. The implants consist of tantalum markers (per ASTM F560) that enable viewing the implant position under imaging. These implants are intended for use with supplemental spinal fixation and bone graft. The implants are provided in both sterile and non-sterile configurations.

"CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space). "LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Lumbar NTRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage. Lumbar NTRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.

The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a complete line of interbody cages for the cervical levels C2-C7 and the lumbar levels L2-S1 to be used with supplemental fixation and bone graft material. The cages are made of silicon nitride material and are available in a variety of widths, lengths, and lordotic angles, (parallel angles to accommodate varying degrees of lordosis and varying patient anatomy). The NITRO Interbody Fusion Cage System Family consists of hollow intervertebral spacers with an axial void designed to hold bone graft material. The bone graft is packed into and around the cage to further facilitate fusion. Each system includes a complete set of instruments to implant the devices properly. The NITRO Interbody Fusion Cage System Family consists of following systems: - MATISSE NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System. - MONET NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System with Supplemental fixation. - MONDRIAN NITRO Lumbar Interbody Fusion Cage System: - о MONDRIAN NITRO ALIF/OLIF Cage System - MONDRIAN NITRO DLIF Cage System о - O MONDRIAN NITRO PLIF Cage System - о MONDRIAN NITRO TLIF Cage System The NITRO Interbody Fusion Cage System Family includes implants and instruments. The subject system uses the same instruments and fundamental technology as do their functional counterparts in CTL Medical's already cleared MATISSE, MONET, and MONDRIAN surgical instruments. As with the predicates, the subject device is implanted using a combination of device-specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.

The MONET Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft or any FDA-cleared Cervical Cage System.

The MONET Anterior Cervical Plate System is an anterior cervical fixation device used to provide structural stability in skeletally mature individuals. The system is comprised of plates, screws and instruments to facilitate the installation of the implants.The plates are available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The CASSATT™ SU Fixation System is intended for fixation of sacroiliac joint disruptions and intended for sacrolliac joint fusion for conditions including. · Sacroiliac joint disruptions, · Degenerative sacroiliitis, · To augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The CASSATT™ SIJ Fixation System is a cannulated screw system, including head washer. The system offers various sizes to accommodate a wide range of anatomies. These devices come in various sizes to accommodate patient anatomy, which are all manufactured from titanium alloy, as specified in ASTM F136.

The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).

The MONDRIAN ALIF Cage with Supplemental Fixation Plate System are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals. The system is comprised of spacers, plates, screws and instruments to facilitate the installation of the implants. The spacers are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136, plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The CTL Amedica Navigation Instrument System are manual surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of this navigation system provides the surgeon access to real-time, multiplane 3D images (and 2D images) providing confirmation of hardware placement. The Navigation Instruments include the following: - Drivers - Taps - Awls - Probes Use of the Navigated Instrument System is limited to Taps ranging in sizes from 4.5mm to 8.5mm in diameter. The Navigation Instruments are to be used with the following CTL Amedica Systems but not limited to: - RAPHAELTM Pedicle Screw System Family - PICASSO II™ MIS Spinal System Family - TAURUS™ Pedicle Screw System Family The CTL Amedica Navigation Instruments are designed for use only with the hardware and software of the Medtronic StealthStation Navigation System. The CTL Amedica Navigation Instruments are manufactured from Stainless Steel and Aluminum. All of these materials conform to ASTM F899.

The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.

The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate devices.

MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. If the MONET Anterior Cervical Interbody Fusion Cage System is used without the Supplementary Fixation Plate assembly, note that supplementary fixation is still required.

The subject device consists of a plate and bone anchoring screws which are made of titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. The anterior fixation plates can only be assembled with the predicate K172788 cage prior to final use. The final assembly constructs are implanted using a combination of device specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899. MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is considered an enhanced and modular line-extension to already cleared MONET™ Anterior Cervical Interbody Fusion Cage System (K172788). The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate have the same risk classification, intended use, and generic designation, as the predicate system the MONET™ Anterior Cervical Interbody Fusion Cage System (K172788). The system is offered in various sizes and configurations to accommodate anatomical variation in the cervical vertebral levels and/or patient anatomy.