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SOURCE: Maxx Medical
Maxx Medical's new Stabilizing Stemmed Tibial Baseplate Option for Total Knee Replacement Receives US FDA, European CE Mark and Indian DCGI Approval.
Dubai, UAE and Plymouth Meeting, PA (PRWEB) March 06, 2013
Maxx Medical, Pvt. Ltd., a global medical device company, today announced that its newly-developed Stemmed Tibial Baseplate (“Stemmed Tibia”) component for the Freedom Total Knee® System ("Freedom Knee") has received US FDA, European CE Mark and Indian DCGI approvals. The Company is showcasing the Stemmed Tibia during the ICJR-Middle East Conference, which commenced today in Dubai.
Freedom Knee is a complete primary knee replacement system developed collaboratively by leading orthopedic and biomedical design experts to provide multiple component size and proportion configurations that deliver high-flexion motion while conserving bone. The Stemmed Tibia is an additional component option to the Freedom Knee system that can be used during primary or revision knee surgery, according to patient needs. It offers surgeons a new option during surgery to provide additional stability for patients with limited bone stock or extensive bone deformities.
The Stemmed Tibia is one of the most bone conserving, low profile stemmed baseplates available on the market. It offers all of the benefits of Freedom Knee’s innovative tibial baseplate locking mechanism technology, plus additional features including:
-Stability - Designed to resist baseplate lift-off due to tilting that can result from poor bone stock.
-Size - Available in 24 stems, ranging from 7.5mm X 75mm to 16.5mm X 150mm.
-Flexibility - Interchangeable between all stem-able Freedom Knee tibial components, featuring straight stem extensions and offset adapters for optimal canal fill and component positioning. This includes an indexable 360-degree adaptor to facilitate exact offset stem placement, as well as neutral 4mm and 6mm offsets.
-Surgical Technique – Simple and reproducible surgical technique, featuring easy, intra-operative component assembly with minimal additional instrumentation.
“Our design approach has always been focused on innovative size, fit and component compatibility configurations to promote high-flex motion while minimizing bone loss. Adding a Stemmed Tibia component option for Freedom Knee opens up even more stabilizing options for both primary and revision knee replacement surgeries,” Ashesh Shah, CEO, Maxx Medical said.
Launched in 2009, Freedom Knee recently received leading analyst group Frost & Sullivan’s “Product Differentiation Excellence Award in Orthopedic Knee Joint Replacement.” Freedom Knee has received US FDA, State Food & Drug Administration P.R. China (SFDA), Drugs Controller General of India (DCGI) and CE Mark approvals. Freedom Knee is manufactured in the United States.
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