Search Results

The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system. the XIA Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint which is fused; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium. When used as a pedicle screw fixation system, the XIA Spine System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

The XIA Spine System is a spinal fixation device for the noncervical spine. It consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. The components are manufactured from titanium.

The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.

The Howmedica Humeral Intercalary System consists of a stem section with a body that may be attached to: 1) another stem section with body; or 2) a proximal bone cap. The stem section of the Humeral Intercalary System is fluted, and is available in diameters of 9mm and 11mm, with multiple body lengths. Both the stem segment and the proximal bone cap contain lap joints, which are joined by the use of machine screws that are available in diameters of 3 - 5 mm, and lengths of 15-20 mm. The attachment of one stem segment to another stem segment is used when there is bone loss/resection of the mid-section of the humerus. The distal stem segment is cemented into the distal segment of the humerus, and the proximal portion is cemented into place in the proximal fragment of the humerus. The stem segments are joined by the use of the machine screws noted above. If the proximal portion of the humerus is not present or has been resected, the bone cap segment is used proximally. There are suture holes in the bone cap to allow the passage of sutures to anchor the device proximally to the shoulder girdle (if this remains in place), or to the chest wall. The distal stem segment is cemented in place in the distal segment of the humerus. The bone cap is attached to the distal stem segment by the use of the screws noted above. These components will be manufactured from titanium allov (Ti-6Al-4V) which conforms to ASTM F-136.

The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral, tibial and humeral fractures. This line extension is to include a humeral nail, cross-locking screws and end caps. The humeral nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.

The Leibinger Burr Hole Covers are designed to be used with fixation screws to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps. The Leibinger Two and Four-Hole Straight Plates are intended for fixation of small bones, including the craniofacial skeleton and midface bones, the fixation of facial bones following elective osteotomies and internal fixation of fractures of the hand. The Leibinger Temporal Gap Plates are intended for use with patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provide fixation and stabilization of cranial bone flaps.

The Burr Hole Cover has a segmented plate-like structure. These Burr Hole Covers are 0.5mm thick and are comprised of four different configurations. The Titanium Two and Four-Hole Straight Plates are holed plates which are attached to bone using screw fixation. They are similar in design to the straight plates of the Wurzburg Titanium Mini Bone Plating System. These plates are 0.5mm thick. The Titanium Temporal Gap Plates are holed plates which are attached to bone using screw fixation. The configurations vary to accommodate the level of reconstruction required for the patient's anatomy.

The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, hone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

This G/K line extension includes solid femoral nails (SFN) and solid tibial nails STN) which may be used with cross-locking screws for intramedullary nailing of femoral and tibial fractures, respectively. The nails can be inserted with or without reaming using an opened or closed technique. They can be locked statically or dynamically. Also, there is an optional nail plug available to prevent tissue infiltration. All of the components are fabricated from medical grade stainless steel.

The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.

The Extracranial Radiotherapy System is a device consisting of a carbon fiber table, a patient support cushion and lateral support panels, stereotaxic plates and related fasteners and assembly tools. During treatment the patient lies supine on the fitted cushion. Four stereotaxic plates surround the patient during CT imaging, with one plate between the support cushion and the table, two placed laterally and one above the patient. Target positioners on the support assembly are used to align the table with the linear accelerator coordinate axes and to verify the target point for treatment.

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary ingromented reconstruction of the proximal femur and acetabulum, respectively.

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum. These devices are identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface.

The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.

The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.

The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.

This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.

The Exeter II Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

The Exeter Intramedullary Bone Plug is a molded acrylic device that is designed to be placed in the femoral canal prior to the insertion of a femoral stem. The bone plug restricts the migration of bone cement down the femoral canal and permits cement pressurization within the canal. The Bone Plug is a cone shaped device available in a range of diameters to accomodate various anatomical requirements. The distal portion of the plug is designed with circumferential ridges that create an interference fit between the plug and the femoral canal. Slots are cut into the ridge portion of the bone plug to allow the plug to compress slightly during insertion down the canal. The body of the plug contains a threaded portion for use with an insertion instrument.