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ATTUNE Knee System Performance• Reduce condylar sliding kinematics3• Higher stability between tibial implant and the bone4Enhanced Initial Stability• Optimal Peg Location to help prevent cortical impingement1• Scalloped Peg Design• Extended Cruciform KeelAdvanced Biological Fixation• Reduced Choke Points to promote in-growth2• Diamond tread surface to increase coecient of frictionATTUNE® AFFIXIUM™Cementless Fixed Bearing Knee with 3DP Technology
2 ATTUNE® • Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP TechnologySince its introduction in 2013, the ATTUNE Knee System has continued to innovate and expand to meet the ever-evolving needs of patients, staying true to the same kinematic features and patented technologies used in the original design. In the past several years, the demand for cementless knee replacement is increasing5, specically for more active patients for whom biological xation may help meet the demands of their active lifestyle today and into the future.Built on the foundation of the ATTUNE Knee System’s comprehensive size range for optimal coverage, the tibial base structural design is designed to provide enhanced initial xation.Extended Central Cruciform KeelProximally coated with AFFIXIUM 3DP Technology, the central cruciform keel is longer than competitive stem designs and is designed to provide torsional and transverse stability.Optimally Located Peg FixationThe 4 peripheral porous pegs feature scallops that allow for comparable insertion force, but achieve higher pull out force vs leading competitor peg design.6Designed for Initial StabilityDiamond Tread Surface TextureOptimal Surface FrictionAFFIXIUM 3DP Technology features a diamond tread surface to increase the coecient of friction
3Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP Technology • AT TUNE®Performance for Cementless FixationMore Stable KinematicsThe ATTUNE Knee System is designed to have stability through motion. In particular, the ATTUNE GRADIUS® Curve works with the soft tissues of the knee to reduced condylar sliding versus other widely available knee systems.3Benchtop testing demonstrated better implant stability vs. leading competitor designsDue to the ATTUNE Knee proprietary technologies reducing the stresses through the implant, the tibial base structural design, and the AFFIXIUM 3DP Technology diamond tread surface, the ATTUNE® AFFIXIUM™ Knee demonstrated lower micromotion during Gait versus leading competitive designs.4Signicant dierences observed in gait for ATTUNE® vs Leading Competitor 1 (p=0.003) and vs Leading Competitor 2(p=0.016)Average Micromotion (Microns)ATTUNE® CRLeading Competitor 1Leading Competitor 2250200150100500MicromotionGait OrtholoadStair Descent OrtholoadCR Implants During Stair Descent, Lateral CondyleA/P Translation (mm)6420-2-4-610 15 20 25 30 35 40 45 50 55 60Flexion Angle (Deg)ATTUNE® CRLeading Competitor 1Leading Competitor 2
4 ATTUNE® • Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP TechnologyReproducible Biological FixationAFFIXIUM 3DP Technology has been designed with controlled variation of pore size distribution to prevent ‘choke points’ (pores less than 100 microns) which could prevent bone to grow into the porous structure. Benchtop testing has revealed the potential for improved bone in-growth vs competitive technologies as AFFIXIUM 3DP Technology has few ‘choke points’ and increased surface porosity.2,7,8AFFIXIUM™ 3DP TechnologyAFFIXIUM™ 3DP Technology is a porous structure that was designed utilizing 3D printing to create a reproducible porous surface for biological xation. The design philosophy is to control pore size distribution instead of randomization to enhance bone ingrowth.AFFIXIUM has 90% lower choke points than other leading porous structures.TM®1.0%0.0%1.0%0.5%1.5%AFFIXIUM™1.1%0.1%Tritanium®Vol. Fraction of ‘choke’ points at surface2,7,8High surface porosity allows high amount of bone inter-digitation at metallic implant surface.TM®4030400200600AFFIXIUM™503590Tritanium®Surface Pore Size (microns)2,7,8
5Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP Technology • AT TUNE®Studies demonstrate Bone In-GrowthA combination of high bulk porosity produced maximum bone ingrowth in a 12 week animal study. The results of the study’s results found AFFIXIUM 3DP Technology to be equivalent to another published study of a leading competitor porous structure.9Increased Mechanical StrengthAFFIXIUM 3DP Technology utilizes a stronger titanium alloy and has been designed to maintain structural strength.10 Additionally, a post process heat treatment step is used in order to create a porous structure that is free of internal poredefects.11,12ATTUNE FB Tibial Base demonstrating no pores.Market Leading Tibial Base Pegs showing pores.584736210Total Bone within Implant (mm2)Porocoat Eqiv AreaTotal Implant Area55–5055–25 65–25 65–50 POROCOAT65% Porosity and 25% RandomizationPores
6 ATTUNE® • Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP TechnologyThe proven clinical success of POROCOAT® Porous Coating13 along with the established eciencies of the INTUITION® InstrumentationCR and PS Femoral ComponentsThe ATTUNE Cementless Knee is available in Cruciate Retaining or Cruciate Sacricing, and Posterior Stabilized constructs. Designed with porous femoral lugs which increases the amount of stability of the femoral component and results in greater dissociation strength and reduced micromotion.The inner A/P femoral surfaces have been designed to ensure that the anterior, posterior, and distal faces achieve full seating onto the bone. While the anterior and posterior chamfers have the addition of a small elevated rail on the medial and lateral edges designed to provide peripheral xation in the chamfer regions without disrupting distalseating.INTUITION® InstrumentsThe INTUITION® Instruments combines the surgical process with intuitive and ecient instruments that enable the surgeon to balance the soft tissues and precisely control the implant position and t for each patient. Two full trays and two half trays have been added to the INTUITION Instruments to accommodate the cementless system. These include the Tibial Trial and Preparation Case, FB Tibial Preparation Case, Femoral Cut Assessment Instruments, and Tibial Protection Plate Case. This set conguration could be streamlined by using our essential kitting option.40030020010035025015050Micromotion (µm)Gait Study140P=0.002*P=0.004*P=0.006*P=0.018*P=0.013*ATTUNELCSRegion of Interest (ROI)ANT MA LA MD LD MP PM PLLPLess micromotion: Overall, micromotions of the ATTUNE Knee System were signicantly lower than the LCS® COMPLETE Knee System under both loading conditions (P≤0.001).
7Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP Technology • AT TUNE®Current robotics in TKA are complex, the solution is simpleThe ATTUNE® Knee System continues to grow its portfolio and technologies to provide a broad range of solutions for patients.The VELYS™ Robotic-Assisted Solution was born from the desire to create a new chapter in robotic TKA. This system not only performs with accuracy and consistency, but it also has a streamlined, ecient design that integrates into the OR.15 When purposeful design meets performance, even advanced workows are made simple.16Improved patient reported outcome measures compared to other leading knee systems that weretested.21Implant survivorship estimate is ≥96.6% at veyears in National Joint Registry for England, Wales, Northern Ireland and the Isle of Man Implant Summary Report, Michigan Arthroplasty Registry, AOA NJR22-2439% lower odds of patient discharge to a skilled nursing facility for ATTUNE Knee patients vs patients who received TKA with a Triathlon™ Knee, according to the results of a large U.S. hospital administrative databasereview.25Valuable InsightsGap balance data to help surgeons visualize and predict joint stability.Versatile ExecutionInstinctive, integrated design to give surgeons the control they’re used to while optimizing daily OR ow.16Veried PerformanceAccurate, consistent plan execution supporting ATTUNE® Knee System in providing better patient outcomes.17-20ATTUNE® Knee Comprehensive PortfolioATTUNE S+™ Technologywith Macrolock and MicroblastATTUNE®RevisionRP and FBATTUNE®Revision LPS UniversalInsertATTUNE®Cementless RPATTUNE®Cementless HybridATTUNE®Cementless with AFFIXIUM™ 3DP TechnologyATTUNE®Medial Stabilized SystemKINCISE™ Surgical Automated SystemVELYS™ Digital SurgeryPatient Specic ALIGNMENTATTUNE®EvidenceTRUMATCH® Personalized SolutuionsVELYS™ Robotic-Assisted SolutionVELYS™ Insights & Patient PathATTUNEGRADIUS™CurveSOFCAM™ContactLOGICLOCK™Tibial BaseGLIDERIGHT™ArticulationINTUITION™ Instruments
Distributed by: DePuy Orthopaedics, Inc. 700 Orthopaedic DriveWarsaw, IN 46582USATel: +1 (800) 366 8143Fax: +1 (800) 669 2530depuysynthes.com DePuy International, Ltd.St Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0) 113 270 0461 DePuy Ireland UCLoughbeg, RingaskiddyCo. Cork, IrelandTel: +35 (321) 491 4000Fax: +35 (321) 491 4199© DePuy Synthes 2021. All rights reserved. 168686-210301 DSUSPlease refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions.For further information on DePuy Synthes products, please contact your local DePuy Synthes representative.The third-party trademarks used herein are the trademarks of their respective owners.References1. DePuy Synthes DVA-107010-DVER report. Adaptiv, 20132. DePuy Synthes WR150265 report, Adaptiv, 20193. Fitzpatrick, et al, The Inuence of Design on TKR Mechanics during Activities of Daily Living, ORS 2012, Poster #20344. DePuy Synthes TR-000002196 report, Adaptiv, 20185. DRG Q3 2018 Construct Report.6. Kane, R; Miltner, N; Smith, B; Tong, W; Initial mechanical stability of additively manufactured pegs in cancellous bone, ORS, Poster No. 1772, 2020.7. DePuy Synthes WR150266 report, Adaptiv, 20198. DePuy Synthes WR150267 report, Adaptiv, 20199. W. Tong, B. Smith, et al 2020 ORS paper No 337.10. ASTM F67 (unalloyed Ti), ASTM F3001 (Ti64 ELI), ASTM F560 (unalloyed Ta)11. S. Leuders, M. Thone, A. Riemer et al, International J of Fatigue 48 (2013) p300-30712. DePuy Synthes WR150180 report, Adaptiv, 201913. McMahon SE, Doran E, O’Brien S, Cassidy RS, Boldt JG, Beverland DE. Seventeen to Twenty Years of Follow-Up of the Low Contact Stress Rotating-Platform Total Knee Arthroplasty With a Cementless Tibia in All Cases. J Arthroplasty 34(3): 508, 2019. 10.1016/j.arth.2018.11.024.14. Berahmani S, Hendriks M, Wolfson D, Wright A, Janssen D, Verdonschot N. Experimental pre-clinical assessment of the primary stability of two cementless femoral knee components. J Mech Behav Biomed Mater. 2017 Nov;75:322 329. doi: 10.1016/j.jmbbm.2017.07.043. Epub 2017 Jul 27.15. Doan G, Curtis P, Wyss J, Clary C. Resection Accuracy Improved during Robotic-Assisted Total Knee Arthroplasty (December 2020). Internal Report 103720852.16. User experience evaluation of the VELYS Robotic-Assisted Solution for total knee (July 2020). Internal Report 103744839.17. Hamilton WG, Brenkel I, Clatworthy M, et al. Comparison of existing and new total knee arthroplasty implant systems from the same manufacturer: a prospective, multicenter study, 2019. Poster presented at: American Academy of Orthopaedic Surgeons 2019 Annual Meeting; March 12–16, 2019; Las Vegas, NV. Poster PO614.18. |Fisher D, Parkin D. Optimizing the value of your patients’ TKA: how to leverage data from patient reported outcomes. Becker’s Hospital Review webinar. October 3, 2019. Accessed October 18, 2019. www.ATTUNEevidence.com/clinical-evidence. 19. Ranawat CS, White PB, West S, Ranawat AS. Clinical and radiographic results of ATTUNE and PFC SIGMA knee designs at 2-year follow-up: a prospective matched-pair analysis. J Arthroplasty. 2017;32:431-436. 20. Indelli PF, Pipino G, Johnson P, Gracea A, Marcucci M. Posterior-stabilized total knee arthroplasty: a matched pair analysis of a classic and its evolutional design. Arthroplasty Today. 2016;2:193-198.21. Hamilton W, Brenkel I, Clatworthy M, Dwyer K, Himden S, Lesko J, Kantor S; Early Outcomes with a New Primary TKA System vs. Contemporary TKA: Interim Results of Two Worldwide, Multi-Center Prospective Studies; Poster #106, AAOS 201722. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 17th Annual Report. (2020). Table 3.K7(a). Full summary of all data is available from: www.njrreports.org.uk 23. Hughes RE, Hallstrom BR, Zheng H, Kabara J, Cowen M, Igrisan R, Richmond A. (2019) Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI) Report: 2012-2018. University of Michigan, Ann Arbor.24. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip Knee & Shoulder Arthroplasty Annual Report 2020,AOA, Adelaide; 2020: 249, 281-282, Tables KT7. (Accessed 1 October 2020 from https://aoanjrr.sahmri.com/annual-reports-2020 25. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Eectiveness of ATTUNE® Versus Triathlon™ Total Knee Systems: Real-World Length of Stay and Discharge Status.” Value in Health 19(3): A298