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Spectrum Spine Cervical Cage System

The Spectrum Spine Cervical Cage System devices including those with macro-, micro- and nano roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of nonoperative treatment. The Spectrum Spine Cervical Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or cortico-cancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

Spectrum Spine Lumbar Cage System

The Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DDD is defined as discogenic pain with degeneration of the disc. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six months of nonoperative treatment. The Spectrum Spine Lumbar Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the lumbar spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate or a combination thereof.

Spectrum Spine Cervical Cage System

The Spectrum Spine Cervical Cage System is composed of cervical interbody fusion devices. The Spectrum Spine Cervical Cage System is offered in five footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The device incorporates Spectrum Spine's proprietary BioBraille nano-feature surface design to improve fixation to adjacent bone. The Spectrum Spine implant surfaces undergo a surface alteration to create features at the nanometer level (10-9). These features have demonstrated the ability to elicit an endogenous cellular and biochemical response. These features meet the requirements of a nanotechnology as outlined by FDA nanotechnology guidance document.

The Spectrum Spine Cervical Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.

Spectrum Spine Lumbar Cage System

The Spectrum Spine Lumbar Cage System is composed of lumbar interbody fusion devices. The Spectrum Spine Lumbar Cage System is offered in multiple footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The device incorporates Spectrum Spine's proprietary BioBraille nano-feature surface design to improve fixation to adjacent bone. The Spectrum Spine implant surfaces undergo a surface alteration to create features at the nanometer level (10-9). These features have demonstrated the ability to elicit an endogenous cellular and biochemical response. These features meet the requirements of a nanotechnology as outlined by FDA nanotechnology guidance document.

The Spectrum Spine Lumbar Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.

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The SpinePoint Flex-Z™ Cervical Cage is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies) at multiple contiguous levels from C2-T1 spine using an anterior approach. The SpinePoint Flex-Z™ Cervical Cage is intended to be used with supplemental fixation systems and with allograft/allogenic bone graft, comprised of cancellous, cortical, and corticocancellous bone to facilitate fusion. Patients should receive 6 weeks of non-operative treatment prior to treatment with the SpinePoint Flex-Z™ Cervical Cage.

The SpinePoint Flex-Z™ Cervical Cage is an intervertebral body fusion device additively manufactured Grade 23 titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The device consists of lattice and a z-shaped frame to improve the stability of the spine while supporting fusion. Additional features include a graft window for packing bone graft and porous endplates to ensure placement is maintained after insertion and aid in osseointegration.

The Flex-Z™ Cervical Cage is available in multiple footprints, heights, and degrees of lordosis to accommodate patient anatomies and surgical approach. Implants are provided sterile in sterile packaging, are single-use only, and are intended to be used with FDA-cleared fixation devices such as an anterior cervical plate system.

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The SWINGO-3D Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine, at one or two contiguous levels, from L2 to S1 whose condition requires use of interbody fusion combined with supplemental fixation.

These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

Patients should have had six months of non-operative treatment prior to surgery.

The SWINGO-3D Lumbar Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the SWINGO-3D Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The SWINGO-3D Lumbar Cage System consists of three different models of additively manufactured lumbar interbody fusion devices—SWINGO-P-3D (PLIF), SWINGO-T-3D (TLIF), and SWINGO-L-3D (LLIF) – that are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. These devices consist of additively manufactured titanium alloy (per ASTM F3001) cages of various heights and footprints, which can be inserted between two lumbar to give support and correction during interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft material. The subject additively manufactured implants are provided sterile via gamma irradiation.

The subject devices are modifications to the nearly-identical devices cleared by Shanghai Sanyou in the predicate submission (K230872). Shanghai Sanyou and Implanet have entered into an agreement in which Implanet will be the legal manufacturer of the subject devices and Shanghai Sanyou will be the contract manufacturer. Under the terms of this agreement, Implanet will maintain the quality system and handle all complaints related to the devices in this submission.

Previously cleared (K163422 and K211689) associated device specific and universal instruments are available to facilitate the implantation of interbody devices. All instruments are manufactured from instrument-grade stainless steel that conforms to ASTM F899. No new instruments are being added.

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The Ventana® A Anterior Lumbar Interbody System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level(s). The Ventana® A Anterior Lumbar System is intended for patients who have had at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

The Ventana® A Anterior Lumbar Interbody System may be used as a standalone device when used with three integrated fixation screws and has a lordotic angle of 20° or less. When an interbody device with fewer than three screws is used, supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.

The Ventana® A Anterior Lumbar Interbody System is an integrated intervertebral body fusion device for use in lumbar spinal surgery. Ventana® A Anterior Lumbar Interbody System devices are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The devices include a lid which further facilitates the installation of bone graft.

The interbody devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001 and machined titanium alloy (Ti-6Al-4V ELI) components conforming to ASTM F136. The interbody device includes three screw holes to accept bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.

All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems.

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The Duet™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.

The Duet™ Spinal Fixation System is a spinal fixation device intended to immobilize and stabilize spinal segments as an adjunct to fusion in the lumbar and sacral regions of the spine. The Duet™ Spinal Fixation System is a dual screw system that eliminates the need for standard pedicle system rods. All components of the Duet™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI.

The Duet™ Spinal Fixation System construct of three components: halo-screw, sphere screw, and set screw. Both screws are offered in various lengths to accommodate individual patient anatomy. The Duet™ Spinal Fixation System is intended to be used at 1-level of the spinal segment to provide supplemental fixation.

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The LUX Expandable Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). LUX Expandable Lumbar Interbody System implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The LUX Expandable Lumbar Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Xenix Medical LUX™ Expandable Lumbar Interbody System implants are manufactured using Titanium Alloy (Ti-6AL-4V ELI per ASTM F136 and F3001). Implants are available in a variety of footprints and geometric options to fit the anatomical variations of patients. The implants are provided sterile. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

Devices incorporate Xenix Medical's proprietary NANOACTIV™ micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10⁻⁹) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document. In vitro results may not be representative of clinical performance. Note: Supporting Study Data will be provided upon request.

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The Hive™ Standalone Cervical System, including devices with a microscopic roughened surface and micro and nano-scale features, is indicated at one or more levels of the cervical spine (C2-T1) in skeletally mature patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous, cortical, and/or corticocancellous bone.

The Hive™ Standalone Cervical System is intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When used with anchors, or without two screws, these devices are intended to be used with supplemental fixation (e.g. cervical plates or cervical posterior fixation).

The Hive™ C Interbody System, including devices with a microscopic roughened surface and micro and nano-scale features, is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with an interbody fusion device. The Hive™ C Interbody System is indicated to be used with autograft bone and/or allograft bone comprised of cancellous, cortical, and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion (hereafter referred to as bone graft). The Hive™ C Interbody System requires additional supplemental fixation cleared for use in the cervical spine.

The Hive™ Standalone Cervical System consists of additively manufactured interbody fusion cages made from Ti-6Al-4V per ASTM F3001 and screws, plates, and anchors made from Ti-6Al-4V per ASTM F136. The cages, bone screws, and plates were originally cleared via K223190. The purpose of this submission is to add bone anchors as an additional form of internal fixation and include an additional packaging configuration option. The implant components of the Hive™ Standalone Cervical System are offered in a variety of sizes to accommodate patient anatomy and surgical approach. The cage implants are provided sterile while the bone screws and anchors are provided non-sterile.

The Hive™ C Interbody System consists of interbody fusion cages additively manufactured from Ti-6Al-4V ELI per ASTM F001. The interbody cages have a microscopic-roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The Hive™ C Interbody System implants are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants are provided sterile. The purpose of this submission is to modify the indications for use and packaging from the previously cleared system.

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E3D™-C Interbody System includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

E3D™-C Static Interbodies are intended to be used with supplemental fixation (e.g. cervical plates or cervical posterior fixation).

E3D™-C Integrated Interbodies are intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When used with anchors, or without screws, these devices are intended to be used with supplemental fixation (e.g. cervical plates or cervical posterior fixation).

The E3D™-C Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-C Interbody System consists of Interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D™-C Interbodies were designed to be placed via an anterior approach. All Interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version isto be used in conjunction with two (2) screws that are subtractively manufactured from titanium alloy, per ASTM F136 or two (2) anchors that are additively manufactured from titanium alloy powder, per ASTM F3001.

Integrated Interbodies were designed to accept two bone screws or anchors which are used to fixate into the adjacent vertebral bodies. When appropriate, the Integrated Interbodies may be used as a standalone system when used with screws. The Titanium Alloy (Ti-6Al-4V ELI) Interbodies are manufactured using an additive Direct Metal Laser Sintering (DMLS) 3D-printing process which enables the creation of the system's double lattice architecture. The double lattice architecture was designed to encourage bone growth on and through the cage. The Integrated Interbody has two screw holes as well as an integral cam locking mechanism to prevent screw back-out.

The E3D™-C Interbody System's implants are available with and without HAnano Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

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The Luna® Ti Interbody Fusion System consists of a Luna Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-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 I spondylolisthesis or retrolisthesis at the involved level(s). The Luna Ti Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of non-operative treatment prior to receiving the Luna Ti Implant. The Luna Ti Interbody Fusion System is to be used with supplemental fixation.

The Luna® Ti Interbody Fusion System devices are for use in lumbar spinal surgery. The implants have a slightly teardrop circular shape which are made of PEEK material conforming to ASTM F2026, nitinol conforming with ASTM F2063, tantalum conforming with ASTM F560, and a titanium coating conforming with ASTM F67.

The Luna® Ti Interbody Fusion System consists of a titanium coated implant and associated accessories set of disposable and re-usable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The Luna® Ti Interbody Fusion System implant is provided pre-loaded and sterile within a single-use Insertion Tool. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket. Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates. The devices are presented with a large opening throughout the design to allow for the placement of autograft or allogenic bone graft. These devices are intended to be placed through a posterior approach.

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When used as an interbody fusion device, the ProLift® Expandable Spacer System 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. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Lateral Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.

The ProLift® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 26mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Expandable Spacer System components with components from any other system or manufacturer. The ProLift® Expandable Spacer System components should never be reused under any circumstances.

The ProLift® Lateral Fixated is an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral Fixated with components from any other system or manufacturer. The ProLift® Lateral Fixated components should never be reused under any circumstances.

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