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The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

The Mesh Introducer Needle is a combination of a Bone Access Assembly (Single Step Instrument) and a Mesh Assembly. The Bone Access Assembly comprises a cannula (acting as a working channel), a dilator-reamer, and a K-wire. The Mesh Assembly comprises a fabric-made mesh (pouch) through which the bone cement is introduced into the treatment site, mounted on a small diameter injection cannula, provided with a blunt edge stylet.

1. The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones. 2. The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

The Meta-Fix and Fixion FA Intramedullary Nailing Systems consist of the following main components: The nail is an expandable, stainless steel, cylindrical rod without interlocking holes. It is supplied in a reduced diameter. The instrumentation includes, mainly, an insertion handle and a pump. The insertion handle is connected to the nail proximal end; the instrumentation is used for nail insertion and expansion. In addition the system consists of accessory tools.

The Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebrai compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence Fenestrated Introducer Needle, a part of the Confidence Cement Delivery System, is combined of a cannula and a stylet. The cannula has a diamond-shape closed distal tip, and has numerous holes located around its distal section.

The Disc-O-Tech Confidence EX High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence EX High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (22.5 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine; hand, tibia; radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

The SKy System consists of the following components: - Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone. - Delivery system used for the insertion, expansion, and retrieval of the expandable tube. - Instrumentation Set - a set of accessories to assist in insertion and location of the device.

The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components: - Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced diameter configuration and expanded within the bone. - Delivery System used for the insertion, expansion, and retrieval of the expandable tube. - Instrumentation Set a set of accessories to assist in insertion and location of the device.

The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of: - Femoral head and/or neck fractures or non-unions. - Aseptic necrosis of the femoral head and/or neck. - Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with minimal acetabular involvement. The Fixion® Hip System is indicated as a total hip replacement in cases of: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. The Fixion® Hip Stem is intended for cemented or non-cemented use.

The Fixion® Hip System is composed of an implant, inflation device (pump) and an instrumentation set. - Implant comprises femoral stem and head ball, and for total hip replacement - acetabular cup and liner and cancellous bone screws, as detailed below: - A stainless steel Stem, including stem body and neck, which is inserted into the femoral medullary canal and expanded following insertion. - A Head Ball, assembled on the stem neck and articulates within the acetabulum (in hemi-hip replacement) or acetabular cup and liner (in total hip replacement). A unipolar stainless steel head (for hemi- hip replacement), and a cobalt chromium head (for total hip replacement) are available. - A porous coated, cobalt chromium Acetabular Cup, inserted and fixated within the acetabulum. - A UHMWPE Acetabular Cup Liner, which is seated inside the acetabular cup. - Cobalt chromium Cancellous Bone Screws, intended to fixate the acetabular cup to the acetabulum, in cases additional stabilization of the cup is required. - Instrumentation Set - a set of accessories to be used with the Fixion® Hip implants. - Inflation Device (Pump) - a manual pump used to expand the Fixion® stem.

The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components: - √ Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone. - > Delivery System used for the insertion, expansion, and retrieval of the expandable tube. - V Instrumentation Set a set of accessories to assist in insertion and location of the device.

The B-Twin Bone Expander System (B-Twin BE System) is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus.

The B-Twin BE System consists of the following components: - Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone. - Delivery system used for the insertion, expansion, and retrieval of the expandable tube. - Instrumentation Set a set of accessories to assist in insertion and location of the device.