DuraCer. Ceramic Components. The Strong Choice In Ceramics

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1 The Strong Choice In Ceramics

2 is a magnesia-stabilized zirconia (MgPSZ) ceramic material whose combination of physical properties is attractive for use in orthopaedic surgery. Mg-PSZ ceramic often is referred to as ceramic steel. The elastic modulus, small grain size, and highly stable crystalline structure of this ceramic give it superior toughness, strength, and durability for applications that generally call for metal. Its biocompatibility, scratch resistance, and hardness provide long-lasting, low-wear bearing surfaces that are reliable in the most demanding application. has been used successfully in joint replacement for more than 20 years with excellent results. No clinical failures due to fracture, phase transformation, or roughening have been reported after thousands of cases. has been tested rigorously in the laboratory and applied extensively in a broad range of industries. It sets the orthopaedic industry standard in durability, wear resistance, and reliability.

3 The Advantage Micro-hardness superior to cobalt chromium (CoCr) and oxidized zirconium (OxZr) Is not as susceptible to brittle fractures like alumina ceramics Highly scratch-resistant Does not undergo phase transformation Able to be polished smoother than CoCr and will stay smoother An extensive history with no clinical failure of femoral heads and femoral knees 22mm 26mm 28mm 32mm 36mm

4 Chemical & Hydrothermal Stability Unlike yttria-stabilized zirconia ceramic, ceramic does not undergo phase transformation. 2 ceramic shows excellent chemical and hydrothermal stability. 2 Yttria-Stabilized Zirconia head explanted after 9 years head explanted after 8 years Before Before After After

5 Artificial Aging Study Y-TZP (UnAged) Sa= 4.69nm (UnAged) Sa= 8.49nm Y-TZP (Aged 49hrs) Sa= 13.3nm (Aged 49hrs) Sa= 8.0nm Each hour of aging is equivalent to 3-4 years in vivo The aging study found that ceramic is chemically and hydrothermally stable with no increase in roughness or loss of hardness. 2

6 Wear Resistant Yttria-stabilized ceramic heads explanted after 5+ years were rougher than ceramic heads. 2 ceramic femoral head retrievals show no change in monoclinic 2 phase concentration, surface roughness, or micro-hardness with age. The extreme resistance to abrasion and scratching by third body particles reduces the risk of counter-face wear. 4,5,6 20 Average Roughness (nm) After 5+ years In Vivo Increased Roughness Over Time 0 Y-TZP

7 Ceramic Steel 1,2 3.5x harder than OxZr. 1,2 2.5x harder than CoCr. 3.8x less pile-up than OxZr. 3 5x less pile-up than CoCr. 3 ceramic heads are more resistant to scratching and corrosion than metal. ceramic heads are much more resistant to brittle fracture than alumina.

8 Reducing Wear When materials are scratched, the edges are pushed up creating pile-up. Pile-up is the main culprit in counter-face wear. The ceramic exhibits virtually no pile-up. 3 CoCr with considerable pile-up ceramic with virtually no pile-up Load= 30N Load= 30N A diamond stylus (Rockwell C, a conical diamond indenter with a spherical tip radius of 200 μm) is drawn across the flat surface

9 Highly Scratch Resistant ceramic with virtually no pile-up The ceramic femoral head is highly scratch-resistant. The ceramic outperforms both CoCr and Oxinium in a scratch test.

10 Reducing Wear femoral heads have had remarkable wear rates when coupled with Cross-linked Polyethylene (XLPE). What appears to be the true rate of wear is detected after 3.5 million cycles and the wear rate is much lower than that of CoCr. 7

11 A Closer Comparison with Alumina Property Units Alumina Density g/cm Bending Strength MPa Fracture Toughness K IC MPa m 1/ Young s Modulus GPa Hardness GPa Average Grain Size μm The Advantage The higher fracture toughness, lower modulus and higher bending strength results in a material that is a stronger femoral head less prone to fracture and fragmentation.

12 Versatility The unique material properties of allows for femoral heads to be made from 22-36mm diameter with no concerns for fracture. Because of this capability, versatility is not compromised and the surgeon can choose the best option for the patient. Neck Length Diameter 22mm 26mm 28mm 32mm 36mm -3.5mm mm 36mm 32mm 28mm 26mm 22mm

13 The Strong Choice In Ceramics Extremely Safe Remarkably Strong Chemically Stable Extremely Scratch-Resistant Remarkably Versatile

14 Ordering Information 22mm Heads 26mm Heads 28mm Heads Part No. Neck Length Part No. Neck Length Part No. Neck Length WE WE Std. Neck +3.5mm WE WE WE mm Std. Neck +3.5mm WE WE WE mm Std. Neck +3.5mm 32mm Heads 36mm Heads Part No. Neck Length Part No. Neck Length WE WE WE mm Std. Neck +3.5mm WE WE WE mm Std. Neck +3.5mm

15 References 1. Kop AM, et al., J Arthroplasty 2007; 22: Damage of oxinium femoral heads subsequent to hip arthroplasty dislocation. Three retrieval studies. 2. Roy ME et al., J Biomed Mater Res 2007; 83A: Phase transformation, roughness, and microhardness of artificially aged yttria- and magnesiastabilized zirconia femoral heads 3. Roy ME et al., J Biomed Mater Res 2008; Diamond-like carbon coatings enhance scratch resistance of bearing surfaces for use in joint arthroplasty: hard substrates outperform soft. 4. McKellop et al., Trans 54th ORS 2008 #1903. Wear of 5mrad crosslinked-remelted polyethylene against CoCrMo and alumina-zirconia heads under 3rd body abrasive conditions 5. McKellop et al., Trans 52nd ORS 2006 #0638. Effect of femoral head size, material, surface roughness and serum concentration on the wear of 5mrad crosslinked-remelted uhmwpe acetabular cups. 6. Roy et al., Trans 53rd ORS 2007 #1624. Diamond-like carbon coatings to enhance bearing surfaces in joint arthroplasty 7. Roy et al., Accepted for Presentation at the 2010 ORS Meeting 2010 Signal Medical Corporation Signal Medical Corporation 1000 Des Peres Rd. Suite 140 St. Louis MO USA Tel Fax Info Visit us at

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