GENTAFIX® (1, 3, 3MV)

GENTAFIX is a family of polymethylmethacrylate (PMMA) bone cements containing gentamicin antibiotic, available in three viscosities (high, low, and medium). It is indicated for use in hip, knee, and other joint arthroplasty procedures to fix prosthetic components to bone, specifically for two-stage revision surgeries after infection has been cleared.

GENTAFIX consists of a polymeric powder component (containing benzoyl peroxide) and a monomeric liquid component (containing N,N-dimethyl-p-toluidine). The key difference from the predicate is that GENTAFIX's liquid contains a co-monomer in addition to methylmethacrylate, whereas the predicate liquid contains only methylmethacrylate as the monomer. Both polymerize via redox reaction to form hardened cement in situ.

Not stated in this summary. The document references FDA's 'Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement' as the framework for testing but does not cite specific ISO, IEC, or ASTM standards.

The predicate device (CEMEX GENTA, K092773) and subject device both use identical indications for use, are made of PMMA with gentamicin, and are provided sterile in different viscosities. Although GENTAFIX introduces a co-monomer in the liquid component, comprehensive physical, chemical, mechanical, and biocompatibility testing of the final finished cement demonstrates equivalent performance to the predicate, and the co-monomer belongs to the same methacrylate family, raising no new safety or efficacy concerns.