Ceramics for Total Hip Arthroplasty
CeraSurf® Ceramic for Total Hip Arthroplasty
CoorsTek CeraSurf®-p is a state of the art material used for ceramic bearing surfaces in total hip arthroplasty. Comprised of an alumina matrix composite, CeraSurf®-p incorporates advanced toughening mechanisms to improve the performance of the material.
CeraSurf®-p is proven to provide excellent wear performance and longevity for acetabular liners and femoral heads. Both biocompatible and stable, CeraSurf®-p offers favorable performance as compared to the leading ceramic material used for bearing surfaces in total hip arthroplasty.
CoorsTek Bioceramics offers standard specifications for femoral heads and acetabular liners. CoorsTek also offers custom design and manufacturing capabilities for orthopedic hip implant components.
Individual patient needs and requirements will determine the best articulation for total hip arthroplasty. Globally, the three most popular articulations for liner and cup configurations are ceramic-on-ceramic, ceramic-on-polymer, and metal-on-polymer. Combined, >1.4 million ceramic heads and liners are implanted yearly.
CeraSurf®-p alumina matrix composite is comprised of a proprietary blend of alumina and zirconia. The distinct composition of the CeraSurf®-p alumina matrix composite promotes the formation of platelets that enhance the toughness of the material via crack deflection. The homogenous distribution of tetragonal zirconia particles in the composite further increase the toughness via compression of the advancing crack.
The microstructure of CeraSurf®-p enhances toughness by two mechanisms: the first mechanism is crack deflection that occurs at the β-Alumina platelets. The second toughening phenomenon is crack suppression, which is promoted by the homogenous distribution of Zirconia particles within the Alumina Matrix. These toughening mechanisms are depicted below.
|Figure 1: Crack Deflection at the β-Alumina Platelets
||1: Crack Forms → 2: Crack advances in tensile field → 3: β-Alumina grain deflects the crack away from the tensile field and arrests propagation.|
Figure 2: Crack Compression by Zirconia Particles
|1: Crack forms → 2: Crack advances in tensile field → 3: Zirconia particles expand as the crack advances which compresses the fracture and arrests propagation.|
Registry: American Joint Replacement Registry
In over seven years of clinical use , CeraSurf®-p femoral heads and liners have performed comparable to competitive ceramic materials in terms of survivorship.
Customer Regulatory Certifications and Clearances
- US FDA 510k clearance for CeraSurf®-p heads in 2016
- European CE mark in 2012
- ANVISA clearance in Brazil 2011
CoorsTek Bioceramics maintains comprehensive technical files containing technical data and laboratory test results on the biological, mechanical, and tribological properties of the CeraSurf®-p ceramic materials and products for total hip arthroplasty. These files are used to support the regulatory process for device submissions incorporating CeraSurf®-p ceramic femoral heads and acetabular liners.
Quality Systems and Certifications
CoorsTek Bioceramics offers best in class quality standards and testing procedures. CeraSurf®-p ceramics are manufactured in an ISO 13485 certified facility that is FDA CFR 820 compliant. CeraSurf®-p ceramic femoral heads and acetabular liners undergo strict quality control throughout the manufacturing process, from the preparation of the ceramic material through final testing.
Stability and Longevity
CoorsTek is a leading global supplier of technical ceramics. Family owned and operated and in continuous operation since 1910, CoorsTek provides high-performance components to virtually every industry.
CoorsTek Bioceramics has supplied over 5,500,000 critical implantable ceramic components since 2005 under an ISO 13485 and FDA CFR 820 compliant quality system.
Standard Femoral Heads
Standard Acetabular Liners