DOT Coatings
Improving implant performance through titanium anodizing
Titanium Anodizing Type II, DOTIZE® Titanium Anodizing Type III, Coloring
America medical implant solutions DOT Coatings
Anodized surfaces for trauma, spinal fusion, joint replacement and dental components
The anodizing of titanium and its alloys are standard surface treatments for medical devices.
Anodizing Type II, DOTIZE® modifies Anodizing Type III, Coloring the biological and biomechanical primarily impacts the cosmetic properties of devices. characteristics of the implants.
Anodizing Type II, DOTIZE®
Background In searching for methods to improve the Research and use of this coating has dem- internal fixation characteristics of trauma onstrated the technology is biocompat- implants, it was determined that the ible, decreases cold welding potential (e.g. type II anodizing procedure, which had between trauma nail and screw), improves been originally developed for aerospace fatigue strength, increases corrosion applications, provided excellent proper- resistance, provides dry lubrication, and ties in the osteosynthesis environment. suppresses bone growth onto the implant.
User needs met • Easier removal of implants after • Biocompatible surface, with fracture healing reduced risk of ion release
• Lower risk of device fracture • Potential for higher screw through improved fatigue strength pre-loads in application
• Reduction in cold welding • Dark grey coloration can be potential used as an identifier. DOT Coatings
Characteristics The DOTIZE® procedure conforms to the standard AMS 2488 (Aerospace Material Specification).
Final Coating Thickness: ≤ 2 microns
Fatigue Strength: ~10% increases in fatigue strength reported
Corrosion Resistance: ~ 40% increase in corrosion resistance reported
Biocompatibility: Good biocompatibility, with multiple predicates available
Technology The DOTIZE® anodizing procedure During the process the substrate developed by DOT, replaces the thin is melted, while oxide forms and natural oxide film present at the implant integrates into the surface eliminating surface, with a thick oxide coating. micro cracks and pores. The result of This is achieved through an electric the process is a smooth, corrosion spark discharge produced on the surface resistant, anti-galling surface with of the implant while it is immersed in minimal dimensional change. an electrolytic bath containing a strong Titanium and most of its alloys are suit- alkaline solution. able for the DOTIZE® anodizing process.
Anodizing Type III, Coloring
Background The principal purpose of color anodizing Applications cover dental, spinal, is the positive identification of parts orthopedic, and trauma products. during a surgical procedure (e.g. sizes and mating pieces).
User needs met • Improves ease of use • Cosmetically appealing through color identification of component sizes and • Biocompatible surface, with no mating pieces dyes or pigments utilized www.dot-coatingusa.com [email protected] Fax: 260-244-5701 Phone: 260-244-5700 Columbia City, IN46725 335 SouthTowerview Drive DOT America,Inc. m edical implant solutions DOT Coatings DOT’s Experience Characteristics Bibliography Technology America 1.
2. 3. medical applicationsworld-wide. implants andcomponentsusedin anodized (TypeIIandIII)millionsof Since 1998,DOThassuccessfully and theoxygengeneratedreactswith molecules atthesurfaceofimplant, induced electriccurrentsplitsthewater anode inanelectrolyticbath.The The implantistheninstalledasan impacting dimension. oxide andevenoutthefinishwithout acid isperformedtoremovethenative If necessary,alightexposuretoan pink, andgreen. be obtained,includingbutnotlimitedtoshadesofbrown,purple,blue,gold, (20-200nm). Throughprecisecontroltechniques,awideselectionofcolorscan The anodizingtypeIIIcoatingisanextensionofthenaturallyoccurringoxidelayer BSI GroupAmerica. ISO13485:2016 certifiedbythe are validatedanditsqualitysystemis DOT America’sanodizingprocesses DOT’s QualitySystem Biomechanical Effects”A.Baumann,N.Zander with AnodizationTypeII:BiologicalBehaviorand Technical Paper(Unpublished)2005”Ti6Al4V F. Falcao,P.Yaman,M.E.Razzoog,J.B.Dennison Screws AfterCyclicLoading” ”Torque toLoosenSurfaceTreatedAbutment Congress 2002,SanDiego,0308 International AssociationforDentalResearch, W.C. Martin,R.D.Woody,A.W.Miller for fourdifferentscrewmaterialsandsurfaces“ “Implant abutmentscrewrotationsandpreloads J ProsthetDent.2001Jul;86(1):24-32
4. Alloys” 5. Asia. applications intheUS,Europe,and cleared orapprovedintechnology DOT anodizedproductshavebeen able fortheanodizingtypeIIIprocess. Titanium andmostofitsalloysaresuit- surface isperceivedascolor. light wavelengthsreturningfromthe the substrate.Thedifferencein reflect/refract offboththeoxideand transparent allowinglightwavesto The titaniumoxidelayerispartially naturally occurringtitaniumoxidelayer. titanium to increase the thicknessof the #3011461101. US FDAfacilityregistration DOT Americaoperatesunder J. Rychly,F.Lüthen,H-G.Neumann P. Becker,A.Baumann,U.Beck,Kirbs, ”Protein adsorptiononsparkanodizedTitanium” Conference, Barcelona2002 17th EuropeanSocietyforBiomaterials A. Kirbs,U.Beck,H.-G.Neumann P. Becker,A.Baumann,F.Lüthen,J.Rychly, “Spark AnodizationonTitaniumand (ed. G.Lütjering,J.Albrecht),3339-3344 on Titanium,Hamburg2003; Proceedings ofthe10thWorldConference Ti 2003,ScienceandTechnology,Vol.V,
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