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OGM® 1 is a PMMA bone cement intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone. OGM® 1A is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to OGM® 1 and OGM® 1A®. This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data. OGM® bone cements without Gentamicin OGM® 1 is polymethylmethacrylate (PMMA) bone cement: - OGM® 1: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery, The OGM® 1 consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration). OGM® bone cements with Gentamicin OGM® 1A is polymethylmethacrylate (PMMA) bone cement, containing the antibiotic Gentamicin: - OGM® 1A is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery, The OGM® 1A consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).