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Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the ittachment of a solid fusion. Mikron Spinal Fixation System is also intended to provide immobilization 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: Degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Proposed Device is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods (Straight and pre-bent) and setscrews. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The LumFix Spinal Fixation System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The LumFix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rods and a crosslink linking mechanism. The LumFix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. LumFix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.

Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Double Medical Universal Spine System consists of pedicle screws, rods, transconnector and nut etc. It is made of Ti-6A1-4V ELI, which meets ASTM F 136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and is widely used for surgical implants. The proposed devices are provided non-sterile but sterilized by the end user.

MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws. Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Screw placement guides are intended for single use only.

MySpine Pedicle Screw Placement Guides - LP are a design modification to MySpine Pedicle Screw Placement Guides (K132788). MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided K-wire placement. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans. Then, the K-wire is guided through the patient's anatomically matched MySpine LP Guides in order to provide positioning according to the surgeon's preoperative planning. For the standard guides introduced and cleared by FDA in K132788, the holes guide the instruments used to open and prepare the pedicle to the planned entry point. After pedicle preparation, the pedicle screws will be inserted through the guiding hole into the pedicle and the vertebrae respectively. For the LP guides introduced with this 510(k), the guiding holes allow placement of the K-wire. Then, the MySpine guide is removed and the wires are used to insert cannulated implants. As an intermediate step, the surgeon can also use the cannulated awl and/or tap to better prepare the entry point in order to simplify the screw tightening. The components of the MySpine Pedicle Screw Placement Guides - LP include a Drill Guide (PA12 Medical Grade) and Vertebral Bone Models (PA12 Medical Grade). The MySpine Pedicle Screw Placement Guides – LP are single use, external communicating devices with limited (<24 hours) contact duration and are provided in sterile and nonsterile versions.

When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical 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 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 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.™ 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 new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.

The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The Sniper® System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (11-S2/ ilium) in skeletally mature patients. The Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Sniper® Spine System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained. The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® System Implants. The instruments, when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The instruments are also intended to provide a percutaneous approach for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

The Sniper® Spine System consists of a selection of non-sterile, single use, titanium allov screw and connector components, and titanium allov and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

The YAHUA Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use. Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use. This device is intended for single use only.

The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components. The FIREFLY ™ Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan. Patient-Specific Bone Models may also be provided.

The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The WASTON General Spinal System consists of Fixed-Angle Screws, Fixed-Angle Reduction Screws, Rods, Crosslink and Set Screws. The proposed general spinal system is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.