This article is more than 5 years old. Information may no longer be current.
StelKast receives FDA 510(k) clearance for acetabular liners featuring antioxidants, highly crosslinked polyethylene
StelKast announced that it has received FDA 510(k) clearance of their new EXp Acetabular Liners. According to a press release, StelKast also received 510(k) clearance for large diameter cobalt-chrome femoral heads and Biolox delta femoral heads.
EXp, a blend of antioxidant and highly crosslinked polyethylene technology, was developed with the consulting support of Steven Kurtz, PhD and Exponent, Inc.
“EXp polyethylene technology represents an optimal blend of UHMWPE, the antioxidant vitamin E (alpha-tocopherol), and crosslinking for long-term oxidative stability, preservation of mechanical properties and performance,” Peter Stephans, chairman and chief executive officer of StelKast, stated in the release. “Unlike other highly crosslinked materials, EXp polyethylene requires no thermal processing or infusion of antioxidants to stabilize the material. The combination of EXp Acetabular Liners and large diameter heads promotes joint stability. The introduction of EXp polyethylene is just another example of StelKast’s commitment to place emerging technology and high-quality implants in surgeon's hands through cost-effective solutions.”
Full commercial launch of the EXp Acetabular System is planned for July 2011.