StelKast, Inc., a privately held manufacturer and distributor of orthopedic implants for knee and hip replacement, has received 510(k) clearance from the FDA to market its product Exp for the company’s Proven Gen-Flex Total Knee System. EXp is a blend of the antioxidant vitamin E (a-tocopherol) and a cross-linked polyethylene technology that, StelKast affirms, preserves mechanical properties to ensure lasting implant performance.
StelKast’s EXp Cleared for Knees
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According to the news release, StelKast was the first company to introduce this technology in the U.S. in 2011 as an alternate bearing material in hip replacements.
“Incorporating our unique EXp polyethylene technology with our Proven Gen-Flex Total Knee System allows our knee patients to benefit from the extraordinary success currently offered by our hip products, ” said John Reyher, senior vice president and general manager of StelKast. “EXp will further enhance the durability of our knee devices providing orthopedic surgeons with more advanced, cost-effective solutions for their patients.”
Full commercial launch of the EXp knee products is planned for September 2013.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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