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G1 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G1 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

OrthoSteady G Bone Cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

The OrthoSteady G Bone Cement consists of Gentamicin sulphate antibiotic and a two component system consisting of separate, sterile and liquid powder components.

The Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and or creation of a void in cancellous bone in the spine. This includes use during percutancous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are designed for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty in association with cleared spinal polymethylmethacrylate (PMMA) bone cements. The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. Winch Kyphoplasty (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyphoplasty procedure. The low preinflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while flexible proximal catheter allows for easy maneuverability.

V-STEADY and V-FAST bone cements are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

V-STEADY and V-FAST are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty . Bone cements are self-curing systems consisting of liquid and powder components: - the powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization). - The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage. The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-FAST has a low initial viscosity and a long working time allowing to work extremely carefully when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.