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Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

Xenco Medical CancelleX Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from Titanium Alloy (TI-6AL-4V per ASTM F3001-14). The system also includes instruments manufactured using 6061 T6 Aluminum Alloy (per ASTM B211 / B221) and Stainless Steel (per ASTM F899). All system implants and instruments are provided sterile packaged and are intended for single use.

When used as an intervertebral fusion device with bone graft, cervical: Xenco Medical InterAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system). When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover): Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xeno Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

Xenco Medical IntelAlign Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from PEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (per ASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560) markers to assist with radiographic visualization. Stand-alone device constructs additionally utilize a fixation plate and bone screws manufactured from titanium alloy, and a PEEK locking cover. The system also includes instruments manufactured using anodized 6061 T6 aluminum alloy per ASTM B211 / B221. All system implants and instruments are provided sterile packaged and are intended for single use.

The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The Xenco Medical Multilevel CerviKit plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths.

Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed with bone during the healing process

Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.

CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process

Sorrento BioGlass Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) and Bioglass 45S5 (ASTM F1538) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.

CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordoric interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure Titanium (ASTM F67). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

The SETx Pedicle Screw System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion. The SETx Pedicle Screw System is intended for posterior, non-cervical pedicle fixation or anterolateral fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); curvatures (i.e., scoliosis, kyphosis, or lordosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; and failed previous fusion.

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When used as an intervertebral fusion device with bone graft, cervical: Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system). When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover): Xenco Medical Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xenco Medical Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

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The Xenco Medical Posterior Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Xenco Medical Posterior Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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