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Eisertech, LLC Temporary Fixation Pins are indicated for the following: - guide wire for osteosynthesis implants - accessories for external fixation (Steinmann Pin) - application as implant according to the principles of fracture management

The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.

The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications: -Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies) -Spondylolisthesis - -Fracture -Spinal stenosis -Tumors (primary and metastatic) -Failed previous fusions -Pseudoarthrosis -Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

The Eisertech, LLC. Cervical Plate (K113170) is a spinal internal fixation device which is provided in a variety of sizes ranging from 20mm in length. The device is designed to accommodate fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. Instrumentation to facilitate implantation of the cervical plate is included with the device. This instrumentation is the subject of the present Traditional 510(k) submission. Specifically, the present Traditional 510(k) submission seeks to add two additional base material options as well as a surface treatment to all previously cleared instruments for use with the cervical plate system. The purpose of the surface treatment is to add scratch resistance and hydrophobicity to the instruments. There are no changes to the implants and the surface treatment is not being applied to the implants.

The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I 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. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style. Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.

When used as a pedicle screw fixation system, the Eisertech Spinal System is 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 posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment - 3. Fracture - 4. Dislocation - 5. Scoliosis - 6. Kyphosis - 7. Spinal tumor and/or - 8. Failed previous fusion (pseudoarthrosis) The Eisertech Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Eisertech Spinal System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies) - 2. Spinal stenosis - 3. Spondylolisthesis - 4. Spinal deformities - 5. Fracture - 6. Pseudoarthrosis - 7. Tumor resection and/or - 8. Failed previous fusion

The Eisertech Spinal System consists of a variety of polyaxial screws, rods, hooks, locking nuts, and rod-to-rod connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. All components are made of titanium allow per ASTM F136.

The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.

The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications: - Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). - Spondylolisthesis - Fracture - Spinal stenosis - Tumors (primary and metastatic) - Failed previous fusions - Pseudoarthrosis - Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

The Cervical Plate spinal internal fixation device made from titanium alloy (all components are made from ASTM F-136). It is provided in a variety of sizes ranging from 20mm to 110mm in length, and accommodating fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. All plates, regardless of length have a nominal thickness of 1.85mm and width of 18mm. Screws are provided in 4:0mm and 4.5mm diameters and in fixed and variable angle styles. Screws are prevented from backing out of the plate by attaching a separate locking mechanism. The mechanism is either a lock washer, consisting of a set screw attached to a washer, or a lock cover, which is a solid screw whose head captures both bone screws at the level of application.

The PLIF Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I 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. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

PLIF Cage is a hollow, generally rectangular box made The of polyetheretherketone (PEEK) and having titanium x-ray markers. It is provided in a variety of shapes and sizes, and is intended to be filled with a bone graft material. The smallest footprint of the device is 8mm medial-lateral x 20mm anterior-posterior. The largest footprint is 12mm medial-lateral x 30mm anteriorposterior. Available heights range from 7mm to 16mm. The device is available either in a non-lordosed configuration, or with a built-in six degree lordotic angle. The PLIF cage may be inserted via an open or minimally invasive approach. It may be placed singly or in pairs. Bone graft volume of the device is variable depending on the device size; larger sizes have more volume for graft. The smallest graft volume, in the 20x8x7mm non-fordotic device is approximately 354.1mm² (0.4cc), while the largest in the 30x12x16 lordotic device is approximately 3,530mm3 (3.5cc). The surface area of the device contacting the endplates ranges from 118mm² to 220mm2 for the smallest and largest footprint devices, respectively. The PLIF cage may be made either from Zeniva PEEK (Solvav Advanced Polymers, Alpharetta, GA USA) or PEEK Optima (Invibio, Inc., West Conshohocken, PA USA). The particular grade of PEEK used is tracked via product lot numbering and is displayed on the package label.

The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

The Cervical Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.