Synthes Graphic Case & Tray System

The Synthes Graphic Case & Tray System is a modular, reusable sterilization case and tray system designed to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The system is not intended to maintain sterility on its own but must be used with an FDA-cleared sterile barrier such as wraps or rigid containers. It is validated for orthopedic devices including cannulated and mated surface devices made of intrinsically stable metals, composites, and thermoplastics with use temperatures above 135°C, with a maximum load of 25 lbs.

The subject device is a modular system offering multiple case and tray sizes (7.2–20.1 inches length × 9.8 inches width × 1.8–6.5 inches depth) compared to the predicate's single size (20.60 × 9.80 × 2.00 inches). Both use identical materials (aluminum lids/bases, silicone and stainless steel inserts, stainless steel latches) and identical sterilization parameters (270°F/132°C, 4-minute exposure, 20-minute dry time, pre-vacuum steam). The subject system is validated for a higher maximum load (25 lbs vs. 8.5 lbs) and explicitly defines compatible device types and material specifications.

ANSI/AAMI/ISO 10993-5:2009 for biocompatibility testing (in vitro cytotoxicity). Sterilization validation used biological indicators and chemical integrators following standard sterilization efficacy protocols to demonstrate SAL 10⁻⁶. Cleaning validation measured protein and hemoglobin residues as analytes.

The subject device shares the same product code (KCT), intended use (organizing and transporting instruments for sterilization), sterilization method, cycle parameters, and core materials as the predicate CrossRoads Tray System. Nonclinical testing demonstrates equivalent or superior performance: both achieve SAL 10⁻⁶, pass dry time and thermal profiling, show no cytotoxicity, and meet cleaning standards. The subject device's broader size range and higher load capacity represent design enhancements rather than functional differences, while the explicit documentation of compatible device types and materials is a specification clarification that does not alter the fundamental intended use or safety profile.