InterSpace GV Hip Spacer

The InterSpace GV Hip Spacer is a temporary hip replacement device made from PMMA antibiotic-laden cement (gentamicin and vancomycin) with a stainless-steel core, designed for skeletally mature patients undergoing two-stage hip revision surgery for infected implants. It is inserted into the femoral canal and acetabular cavity for up to 180 days while systemic antibiotics treat the infection, after which it must be replaced with a permanent implant or alternative treatment.

The InterSpace GV Hip Spacer incorporates a tapered wedge stem design and stainless-steel reinforcement within PMMA loaded with gentamicin and vancomycin antibiotics. This represents a minor geometric modification compared to the predicate InterSpace G, while maintaining the same materials, single-use disposable format, and sterile delivery.

Not stated in this summary. The document references mechanical testing, antibiotic content analysis, biocompatibility assessment, sterilization validation, shelf-life validation, and packaging validation, but does not cite specific consensus standards (ISO, ASTM, IEC, etc.).

The device is substantially equivalent because it shares the same intended use (temporary antibiotic-loaded spacer for infected hip revision), the same core materials and function (PMMA with gentamicin and vancomycin), and the same clinical application as the predicate InterSpace G. The minor geometric change (tapered wedge stem) was validated through mechanical testing to demonstrate it does not alter the fundamental safety or effectiveness profile compared to the predicate.