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Repair of long bone fractures due to trauma or reconstruction o Reattachment of the greater trochanter in total hip arthroplasty, surface replacement の arthroplasty, or other procedures involving trochanteric osteotomy Sternotomy closure の Sublaminar and intrafacet wiring of the spinal column 0

The Metagen ActiveLock™ Wire Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. There are two versions of the device disclosed in this submission. The fundamental components of each device are a straight, annealed CoCr alloy wire and a novel Clamp device to secure the wire is 16.5 gage (.048 inch) fully annealed CoCr alloy. (ASTM F-799). A Clamp is provided to secure the wire after tensioning. The Clamp is offered in a "Single" configuration, which secures opposing ends of a single wire, and a "Double" configuration, which secures the free ends of two adjacent wires.

The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture. The Clinical Indication for Use is: "The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."

The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion. Modular bistemmed intramedullary rod system with rigid cam locking mechanism designed to provide intraoperative adjustment after cementing components into the proximal and distal segments of the resected humerus. Materials: Ti-6Al-4V NiTi alloy (locking system)

The ActiveLock Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The ActiveLock M Modular Femoral Hip System is a matrix of interchangeable components (STEM, BODY, ACTUATOR, FEMORAL HEAD) that can be locked together to form a single femoral hip prosthesis.

The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.

The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies. Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.

The High Tibial Osteotomy System is a fracture fixation system used to perform closing wedge osteotomies. It consists of L-plates, cortical and cancellous bone screws, and offset staples. Materials: The devices are manufactured from CoCrMo ( cast or Wrought ), Ti-6A1-V, and 316 LVM stainless steel per ASTM standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following osteotomy.