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The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous 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). Patients should have received at least 6 months of non-operative treatment prior to treatment with Hexanium PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the cage as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mm increments), width of 9 mm, lengths of 22 and 25 mm, and lordosis angles of 0°, 5°, and 8°. Hexanium® PLIF cages are provided sterile and supplied with a set of non-sterile surgical instruments.

The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck 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). Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF system includes a set of reusable surgical instruments. The purpose of this Special 510(k) application is to propose minor modifications to the currently cleared surgical instruments. There are no modifications being proposed for the implantable components of the system

When used for anterior screw fixation or as a posterior, non-pedicle system of the U.L.I.S.™ and LUMISTM systems are indicated for: · degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - · spondylolisthesis - · fracture - · spinal stenosis - · curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - tumors - · failed previous fusion (pseudoarthrosis) The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who: - · have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - · receive fusions using autogenous bone graft only; - · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - · have the device removed after the development of a solid fusion. In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1): - · degenerative spondylolisthesis with objective evidence of neurologic impairment - · fracture - · curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - · spinal tumor - · failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile. The purpose of this submission is to include design modification and new diameters and lengths of the LUMIS™ Cannulated Polyaxial Pedicle Screws and U.L.I.S.™ Polyaxial Pedicle Screws, creation of LUMIS™ Cannulated Monobloc Pedicle Screws and U.L.I.S.™ Monobloc Pedicle Screws, addition of CoCr Spinal Rods, and new lengths of UNI-Thread® rods.

When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the U.L.I.S. ™ and LUMIS™ systems are indicated for: · degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - · spondylolisthesis - fracture - · spinal stenosis - · tumors - · failed previous fusion (pseudoarthrosis) The U.L.I.S. ™ and LUMIS™ systems are pedicie screw systems indicated for skeletally mature patients who: - · have severe spondvlolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - · receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - · have the device removed after the development of a solid fusion. In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1): • degenerative spondylolisthesis with objective evidence of neurologic - impairment - fracture - spinal tumor - · failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ Description System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) instrumentations are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods (SpineVision UNI-Thread™ rods or LUMIS™ percutaneous rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied nonsterile. These constructs are assembled using specific instruments. The components of the U.L.I.S.™ and LUMIS™ systems are made of Titanium Ti-6Al-4V ELI complying with ASTM F136 (ISO 5832-3). The components added within this submission include: New reference of LUMIS™ rods (Straight and pre-bent), 12 new instruments for LUMIS™ system, 4 new instruments for U.L.I.S.™ system. The devices provide correction and rigid cannulated. stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).

When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.TM and LUMISTM systems are indicated for: - degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - spondylolisthesis - fracture - spinal stenosis - tumors - failed previous fusion (pseudoarthrosis) The U.L.I.S.TM and LUMISTM systems are pedicle screw systems indicated for skeletally mature patients who: - have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - have the device removed after the development of a solid fusion. In addition, the U.L.I.S.TM and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1): - degenerative spondylolisthesis with objective evidence of neurologic impairment - fracture - spinal tumor - failed previous fusion (pseudoarthrosis)

The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are composed of cannulated (LUMISTM) and non-cannulated (U.L.I.S.TM) pedicle screws and fixation rods (Spine Vision Unithread TM rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. These constructs are assembled using specific instruments. The components of the U.L.E.S.TM and LUMISTM systems are made from ASTM F136 titanium alloy (Ti-6Al-4V ELI) complying with ASTM F136 (ISO 5832-3). The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are manufactured in Titanium alloy complying with ASTM 136. The LUMISTM Pedicle screw system is cannulated. The devices provide correction and rigid stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).