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The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system. Cycle: Dynamic Air Removal Temperature: 270 F/132 C Exposure Time: 4 minutes Drying Time: 10 minutes Validations included the worst case load configurations of the EZ- TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Devices. - . Contents in the validated configuration include reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc) - No lumened devices were validated within the tray system as part of the product load. The EZ-. TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims. - Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices).

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store G7 Acetabular System / Taperloc Complete Hip System Devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterile barrier system. The subject device protects the inteterior components during transportation, sterilization, and storage. The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers. The lids and bottom of travs are fully perforated with an evenly distributed hole pattern. The sides of the travs are partially perforated. The travs are used with locking lids, The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee devices between surgical uses. The EZ-TRAX™ Persona Knee Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

The EZ-TRAX™ Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Persona Knee Devices between surgical uses. The EZ-TRAX™ Persona Knee Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier svstem. The subject device protects the interior components during transportation, and storage. The EZ-TRAX™ Persona Knee Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers. The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids. The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system. Cycle: Dynamic Air Removal Temperature: 270 F/132 C Exposure Time: 4 minutes Drying Time: 10 minutes Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure. - . Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.) - . No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims - Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon Containment devices). The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes: Brand Name: EZ-TRAX™ Model: BASE.ASSY.AL.24.12.2.4 Dimensions: L) 22.97" (W) 11.18" (H) 2.44" Brand Name: EZ-TRAX™ Model: BASE.ASSY.AL.21.12.4 Dimensions: (L) 19.97" (W) 11.18" (H) 4.187"

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Stryker Mako Total Knee with Triathlon Devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system. The subject device protects the interior components during transportation, and storage. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers. The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids. The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

The EZ-TRAX™ Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store medical devices between surgical and other medical uses. The EZ-TRAX™ Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

The EZ-TRAXTM Containment Device includes bases with dividers, lids, and brackets fabricated from a variety of materials commonly used to enclose, protect, and organize non-sterile medical devices. The subject device is not intended to maintain sterility, but it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization wrap. The subject device protects the interior components during transportation, and storage. The EZ-TRAX TM Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers. The lids and bottom of bases are fully perforated with an evenly distributed hole pattern. The sides of the bases are partially perforated. The trays are used with locking lids. The bases / lid assembly was designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.