OsteoRemedies Hip Spacer System

The OsteoRemedies Hip Spacer System is a temporary hip implant (maximum 180 days) used as an intermediate device in a two-stage surgical procedure to treat hip infections in adults. It consists of modular femoral heads and stems made from PMMA (polymethylmethacrylate) reinforced with a stainless steel core, combined with gentamicin or gentamicin/vancomycin, and optional acetabular cups. The device delivers antibiotics locally while maintaining hip joint function during infection treatment, after which permanent components are implanted.

The subject devices include the REMEDY POLY+PLUS Acetabular Cup and REMEDY CoCr Modular Femoral Head, designed as line extensions to previously cleared REMEDY and REMEDY SPECTRUM GV Hip Spacer families. Key characteristics assessed include wear performance, antibiotic elution profiles, range of motion capability, and component interconnection integrity. Sterilization is validated to ISO 11135, 11137, and 11138 standards with a sterility assurance level of 10⁻⁶.

ISO 10993 (biocompatibility evaluation), ISO 11135/11137/11138 (sterilization validation), and FDA Draft Guidance on International Standard ISO 10993 for biological evaluation of medical devices. Performance testing included wear characteristics, elution profile, range of motion assessment, and interconnection assessment.

The subject devices are substantially equivalent to predicate devices (REMEDY Acetabular Cup K192995/K191981/K173967 and REMEDY Hip Spacer K112470/REMEDY SPECTRUM GV K172906) with respect to indications, design materials, function, manufacturing, and performance. Both are temporary hip spacers with antibiotic-eluting PMMA components used for two-stage infection treatment, and verification testing confirmed they meet pre-determined acceptance criteria established for predicate devices.