With the introduction of COPAL® G+C pro, Heraeus Medical extends the portfolio of the All-in-One Fixation System™ product range by its first dual antibiotic-loaded bone cement in a closed mixing system. Alongside the MDR approval of COPAL® G+C bone cement, the corresponding All-in-One Fixation System™ COPAL® G+C pro marks the first closed mixing system by Heraeus Medical to receive the MDR certification.
Currently COPAL® G+C pro is available in selected countries within the Post-Market Clinical Follow-up (PMCF) phase set by the MDR regulation. The broader launch is expected to follow after the end of the study phase.
“It’s great that with this further MDR approval a relevant product from Heraeus Medical in the section of cement simplification is now MDR certified, and we are looking forward to provide our customers with a broadened portfolio in our All-in-One Fixation System™ product range.”, says Nicole Petermann, President of Heraeus Medical.
COPAL® G+C is an antibiotic-loaded bone cement for infection management in arthroplasty. In combination, both antibiotics may target up to 90% of all pathogens typically found in PJI.1
1 Berberich CE, Josse J, Laurent F, Ferry T. Dual antibiotic loaded bone cement in patients at high infection risks in arthroplasty: Rationale of use for prophylaxis and scientific evidence. World J Orthop 2021; 12(3):119–28.
