Refobacin Bone Cement R (110034355)

Refobacin Bone Cement R is a fast-setting acrylic polymer bone cement containing gentamicin sulfate, used to anchor joint prostheses in hip and knee revision arthroplasty operations. It is indicated for stable fixation when reconstruction is necessary due to joint infection or revision of previous procedures, particularly when gentamicin-sensitive bacterial strains are a potential risk, and for the second stage of two-stage revision procedures after initial infection clearance.

The device is similar to its predicate in indications, clinical characteristics, technical/design characteristics, biological materials, manufacturing process, sterilization, and packaging. The primary change is a new source of gentamicin sulfate with larger antibiotic particles that require an additional processing step for precipitation, but this does not alter the final product specifications or performance compared to the predicate device.

ISO 13485 standards are referenced for quality management (design controls, nonconforming product, corrective and preventative actions). The document lists comprehensive non-clinical testing including incipient break & assembly, creep properties, fatigue performance, fracture toughness, porosity, radiopacity, shear strength, tensile properties, and shelf-life verification, but does not cite specific ASTM or other consensus standards by number.

Substantial equivalence is established because the subject device meets the same product specifications as the predicate, demonstrates equivalent mechanical and performance properties through extensive non-clinical testing, maintains identical sterilization and packaging, and the change in gentamicin sulfate sourcing does not impact claimed product performances or patient safety, ensuring product quality is maintained.