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The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, 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 at up to two contiguous levels from C2 - T1. The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including; - sacroiliac joint disruptions - degenerative sacroiliitis - to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and - acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX™ 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The T-FIX™ 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The T-FIX™ screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. T-FIX™ is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The T-FIX™ screws are made from a titanium alloy Ti-6Al-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment when packaged sterile.

The T-FIX® 3DSI Joint Fusion 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 sacrolliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and - acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX® 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The subject T-FIX® 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The subject T-FIX® screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. The subject T-FIX® is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The subject T-FIX® screws are made from a titanium alloy Ti-6A1-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment.

The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis 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. The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal or anterior approach. The CES-LIF is implanted in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA® HA Enhanced spacers offered in a variety of widths and lengths. The CES-LIF are generally rectangular in shape. The CES-LIF is used in pairs. The EVOL® Spinal Interbody System implants are available in a range of sizes to accommodate variations in patients' anatomy. In addition, tantalum beads are embedded in the spacers to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The CES-LIF HA implants themselves are made of biocompatible PEEK-Optima® HA Enhanced (LT120) polymer material and provided non-sterile for single-use. Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior). The purpose of this submission is to add a new sterilization method.

The EVOS Lumbar Interbody System is an intervertebral body device in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis 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. The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 (per ASTM F-2026) and PEEK Optima LT120HA, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs. The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline. Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants. The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials. The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.

The EVOL® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha - D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha - D Lateral Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The EVOL® ha -D Lateral Interbody Fusion System is designed for use as a lumbar interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have two central windows for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.

The EVOL® ha - C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha – C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of nonoperative treatment.

The EVOL® ha - C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have a central window for autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis 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. The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation. The EVOS Lumbar Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis 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. The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA or PEEK-OPTIMA HA spacers offered in a variety of widths and lengths. There are five main configurations: CES-PLIF, CES-LIF, CES-TLIF, CES-CLIF and CES-RLIF. The different configurations allow for multiple surgical technique options. The CES-PLIF, CES-LIF, CES-CLIF and CES-RLIF are generally rectangular in shape while the CES-TLIF is curved. The CES-PLIF and CES-LIF are used in pairs while the other options are used singly or in pairs. The EVOL® Spinal Interbody System implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the spacers as an option to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The implants themselves are made of biocompatible PEEK-Optima Natural (LT1) or [PEEK-Optima HA Enhanced (LT120) - CES-LIF only] polymer material (per ASTM F2026). Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior). The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 and PEEK Optima LT120HA per ASTM F-2026, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs. The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline. Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants. The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials. The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.

The EVOS Lumbar Interbody System (EVOS device) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis 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. The EVOS Lumbar Interbody System is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is an Intervertebral Body Fusion System for the lumbar spine. The EVOS Lumbar Interbody System includes surgical instruments to deliver the EVOS devices via a Posterior or Transforaminal approach. The generally rectangular design of the EVOS device incorporates an internal cavity for insertion of biological bone growth material through the top and bottom openings, as well as four small transverse holes (two on each side) that are designed to enhance bony ingrowth. Each device has a series of ridges or "teeth" on the top and bottom surfaces that are designed to ensure strong anchoring on the vertebral body endplates and resist backing out of the implant. The EVOS devices are provided sterile (gamma irradiated) for single use. The EVOS device is made of radiolucent PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced material. In addition, tantalum beads are embedded in the spacers to allow for radiographic visualization. The geometric shape of the EVOS devices are categorized as either STRAIGHT, CURVED, or ROTATE. All are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. Most of the EVOS STRAIGHT devices are offered with an option of a Standard nose, Wide nose, or Narrow nose. The devices are available in various heights, widths, and lengths to accommodate various surgical technique options.