Freedom Knee® Revision Knee System Receives US FDA 510(k) Clearance Ahead of American Academy of Ort
Plymouth Meeting, PA (USA) and Andheri, Mumbai (India), March 10, 2014 -- Maxx Orthopedics, Inc. a subsidiary of Maxx Medical, Pvt. Ltd., a rapidly expanding global orthopedics device company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Freedom® PCK Components (PCK), the latest addition to its revision knee system.
The Freedom PCK combines Maxx’s previously-cleared Freedom® Stemmed Tibial Components with patent-pending Femoral Components and Constrained Liners, to create one of the most bone conserving, low profile revision knee systems available on the market.
This complete revision knee replacement system was developed to provide a wide variety of component size and stability configurations, while conserving bone. It offers a constrained option to surgeons whose patients require additional stability, without significantly compromising range of motion and rotation. Following the same design philosophy as Maxx’s Freedom Total Knee® primary system, the revision system adds:
Patent-pending progressive constraint, remaining highly constrained in extension and relatively less constrained as the patient increases flexion;
A femoral/tibial size range equivalent to the primary knee system and including liner thicknesses up to 31mm, to appeal to global patient and surgeon populations;
Interchangeability between Freedom Stemmed Tibial Components and PCK Components, using straight stem extensions and offset adapters for optimal canal fill and component positioning;
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 optimize range of motion while minimizing bone loss. The Freedom PCK extends this philosophy to a constrained system, with its progressive constraint design, which we believe makes it the most innovative revision knee system on the market. With the addition of the Freedom PCK, Maxx’s Freedom Total Knee portfolio takes a big leap forward in addressing the needs of surgeons and patients. We are excited to begin sharing this story during AAOS." Ashesh Shah, CEO, Maxx Medical said.
Freedom Knee is a total knee replacement system specifically engineered for high flexion, bone conservation and advanced component size and fit capabilities. Launched in 2009, Freedom Knee received leading analyst group Frost & Sullivan’s “Product Differentiation Excellence Award in Orthopedic Knee Joint Replacement.” Freedom Knee has US FDA, Drugs Controller General of India (DCGI), European CE Mark, and State Food and Drug Administration P.R. China approvals. Freedom Knee is manufactured in the United States.
Maxx will be showcasing the Freedom Knee primary and new revision knee systems during the AAOS Show, held March 12-14 at the Morial Convention Center in New Orleans, LA (Hall E; Booth #3440).
About Maxx Medical
Maxx Medical Pvt. Ltd. ("Maxx Medical") develops and markets innovative orthopedic medical devices on an international scale. The company is focused on providing state-of-the-art implants and related solutions that best restore patient mobility while accommodating lifestyle, anatomical and economic needs. Maxx Medical is the parent company of Maxx Orthopedics, Inc., the manufacturer of the Freedom Total Knee® System. For general information visitwww.maxxmed.com..