Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge.
A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.