iPoly XE HIGHLY CROSSLINKED VITAMIN-E UHMWPE
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HIGHLY CROSSLINKED VITAMIN-E UHMWPE

Patient-specific polyethylene inserts blended with Vitamin-E. ConforMIS iPoly XE is the next generation of highly crosslinked polyethylene blended with Vitamin-E to enhance wear resistance without compromising strength or oxidative stability.1,2 The iTotal® G2 system with iPoly XE offers a complete solution for CR total knee replacement surgery. iPoly XE1 • Improves wear resistance • Prevents oxidative degradation • Maintains mechanical strength HIGHLY CROSSLINKED VITAMIN-E BLENDED UHMWPE

Wear resistance for highly demanding knees Wear Testing Comparison (mg/million cycles)1 • esting was performed in knee simulator comparing iPoly XE tibial inserts T with standard Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of the same shape and design • Poly XE exhibited 48% reduction in wear vs. standard UHMWPE i Results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance.

Preventing oxidation... Oxidation Index (Mean) Oxidation index was zero for all samples • est samples were subjected to accelerated aging T and exhaustive extraction of Vitamin-E • amples were then cut into 0.2mm increments S and analyzed for presence of oxidation Oxidation Index (Mean) Even After Wear and 2 Times Age Testing1 No oxidation even after wear and accelerated age testing • amples were then cut into 0.2mm increments S and analyzed for presence of oxidation • est samples were then subjected to wear testing, T 2x accelerated aging, and exhaustive extraction of Vitamin-E HIGHLY...

• esults indicate iPoly XE has higher ultimate R tensile strength and maintains yield strength vs. standard UHMWPE even when exposed to accelerated aging Yield Strength iPoly XE Aged • esults show iPoly XE maintains equivalent R impact resistance, a measure of brittleness, even after accelerated aging (p=0.56) • atigue testing to simulate crack inception and F propogation was performed comparing aged vs. unaged iPoly XE • esults show iPoly XE maintains equivalent R fatigue strength characteristics even after accelerated aging (p=0.26)

Next Generation Manufacturing Process2 Vitamin–E Blended Ensuring complete integration and molecular bonding without compromising mechanical strength Direct Compression Molded Allowing for optimal homogeneity throughout depth of material Highly Crosslinked Irradiated at 10 Mrad for a strong, high wear-resistant polyethylene insert Mechanically Annealed w/ Proprietary Process Allowing vitamin E to bond with free radicals to prevent oxidation. Performed below melt temperature to prevent degradation of mechanical properties Machined into final, patient-specific shape Providing a highly...

I ndividualized fit that virtually eliminates overhang and sizing compromises • Designed to follow the contour of each patient’s anatomy • Tibial tray designed for maximized cortical rim coverage with prenavigated rotational alignment condylar and trochlear J-curves with matching offset poly inserts SIMPLE SURGICAL TECHNIQUE • R educed number of intra-operative decisions such as implant sizing • Mechanical and rotational alignment are pre-navigated in the individualized iJig instrumentation • iView surgical planning images for proper jig placement and detailed resection values set-up and...

ConforMIS, Inc. • 28 Crosby Drive • Bedford, MA 01730, USA • Phone: 781.345.9001 • Fax: 781.345.0147 Authorized Representative: Medical Device Safety Service, GMBH Schiffgraben 41, 30175 Hannover, Germany All rights reserved. iTotal and ConforMIS are registered trademarks of ConforMIS, Inc. iPoly is a trademark of ConforMIS, Inc. CAUTION: USA federal law restricts this device to sale by or on the order of a physician. The ConforMIS Cruciate Retaining Total Knee Replacement System (iTotal G2) is intended for use only by fully trained physicians. Prior to use of a ConforMIS device, please...