Permallon® Tru Orthopaedic Ceramics

 

The Choice in Orthopaedic Ceramics

Permallon® Tru is a state of the art material used for ceramic bearing surfaces in total hip arthroplasty. Comprised of an alumina matrix composite, Permallon® Tru incorporates advanced toughening mechanisms to improve the performance of the material.

Permallon® Tru is proven to provide excellent wear performance and longevity for acetabular liners and femoral heads. Both biocompatible and stable, Permallon™ Tru 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 femoral head and liner configurations are ceramic-on-ceramic, ceramic-on-polyethylene, and metal-on-polymer. Combined, >1.4 million ceramic heads and liners are implanted yearly.

 

Toughening Mechanisms

Permallon® Tru alumina matrix composite is comprised of a proprietary blend of alumina and zirconia. The microstructure of Permallon® Tru 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.

 

Clinical Use

In over eleven years of clinical use, Permallon® Tru femoral heads and liners have performed comparable to competitive ceramic materials in terms outcomes of survivorship.

 

Customer Regulatory Certifications and Clearances

Devices incorporating CoorsTek Bioceramics products are registered by our customers in locations worldwide. Check for regulatory approval in your area.

RELATED:

• US FDA 510k clearance for CeraSurf®-p (now Permallon® Tru) heads in 2016 

 

CoorsTek Bioceramics maintains comprehensive technical files containing technical data and laboratory test results on the biological, mechanical, and tribological properties of the Permallon® Tru ceramic materials and products for total hip arthroplasty.  These files are used to support the regulatory process for device submissions incorporating Permallon® Tru ceramic femoral heads and acetabular liners.

 

Quality Systems and Certifications

CoorsTek Bioceramics offers best in class quality standards and testing procedures. Permallon® ceramics are manufactured in an ISO 13485 certified facility that is FDA CFR 820 compliant. Permallon® Tru 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 6 million critical implantable ceramic components since 2005.

Specifications

Standard Femoral Heads

 

Standard Acetabular Liners