United Orthopedic Corporation

STERILIZATION 1.This device is sterile and double packaged to ensure the product is suitable for surgery at any time. The sealed package can protect the implants and keep the sterilized condition under normal storage and transport. 2.Inspect packages for punctures or other damage prior to surgery. Metal components are radiation sterilized. Plastic components are radiation sterilized or ethylene oxide sterilized. The method of sterilization is noted on the package label. 3.This device is provided sterile and should be stored in the original packaging until it is ready to be used. 4.Prior to used, check the sterilization expiry date and verify the integrity of the sterile packaging. If the sterilization expiry date has expired or in case of any damage to the protective packaging, the implants must not be used or resterilized and must be discarded or returned to the supplier. In the presence of any flaws, the product must be assumed nonsterile. 5.Care should be taken to prevent contamination of the component. In the event of contamination, this product must be discarded. 6.If the package is opened, but the product is not used, the component must not be resterilized and must be returned to the supplier. STORAGE CONDITIONS All products should be stored in their original packaging in a clean and dry environment and be protected from sunlight and extremes in temperature. SAFETY INFORMATION IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT This device has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of device in the MR environment is unknown. Scanning a patient who has this device may result in patient in patient injury. 90 “UNITED” U2 TM Total Knee System Safety Statement Materials of Instruments Instruments Materials Colorant Step drill, IM Rod handle, Femoral IM rod, Alignment rod, Resection check blade, Femoral chamfer resection guide extractor, Femoral condyle drill, PS Reamer, Tibial EM alignment guide, Tibial stylus, Tibial baseplate trial handle, Tibial insert trial handle, Tibia punch, Patella protector, Patellar clamp, On set patellar drill guide, On set patellar peg drill, Patellar cement clamp adaptor, Patellar clamp ring, Patella reamer stopper, Patellar reamer, Patellar drill guide, Patellar drill, PS Cutting jig drill guide, PS Notch cutting jig, Tibial baseplate trial, Head pin impactor, Tibial augment resection guide, Tibial drill guide(CMA), Straight stem drill Stainless steel, Type 630 None Femoral IM alignment guide, Distal femoral resection guide, Femoral sizer-A/P resection guide (AiO), Femoral chamfer resection guide, Femoral driver, Tibial resection guide, Tibial punch guide, Tibial drill guide, Modular handle, Pin extractor, Caliper, Patellar stylus, On set patellar resection guide, Patellar resection cover Stainless steel, Type 420 None EM alignment tower, Femoral sizer-A/P resection guide, Femoral stylus, Screw driver, PS Housing punch, PS Housing impactor, Tibial drill, Tibial punch handle, Quick pin driver, Threaded pin, Round pin, 3.2mm Drill, Head pin impactor, Head pin Stainless steel, UNS S46500 None Gap spacer, Gap gauge(10/12mm), Tibial sizing template, On set patella sizing ring, Patellar sizing ring Stainless steel, Type 631 None Distal femoral alignment guide Stainless steel, Type 304 None Femoral trial CoCrMo None Patellar drill depth sleeve, Tibial insert trial, Patellar trial, Augment trial Polyoxymethylene (POM) Light Blue, Blue, Brown, Gray, Red, Black, Green, Yellow Gap gauge, Universal impactor, Femoral impactor, Tibial baseplate impactor, APT Component impactor, Patellar cement clamp adaptor Polyphenylsulfone (PPSU) White, Black Disposable femoral trial set Polycarbonate(PC) Stainless steel, Type 304 Green, Transparent Disposal tibial trial set, Disposal patellar trial set, Polycarbonate(PC) Green, Transparent