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Maxx Orthopedics receives 510(k) clearance for revision knee system

The FDA issued 510(k) clearance to Maxx Orthopedics Inc. for its Freedom PCK Components.

According to a press release, the Freedom PCK combines the company’s Freedom Stemmed Tibial Components with patent-pending femoral components and constrained liners, to create a bone-conserving, low-profile revision knee system. Developed to provide a variety of component size and stability configurations while conserving bone, this complete revision knee replacement system offers a constrained option for patients who require additional stability without significantly compromising range of motion and rotation.

The revision system remains highly constrained in extension and relatively less constrained as the patient increases flexion. It also features a femoral/tibial size range equivalent to the primary knee system, including liner thicknesses up to 31 mm; and interchangeability between Freedom Stemmed Tibial Components and PCK Components, using straight stem extensions and offset adapters for optimal canal fill and component positioning.

“Our design approach has always been focused on innovative size, fit and component compatibility configurations to optimize range of motion while minimizing bone loss,” Ashesh Shah, chief executive officer of Maxx Medical, stated in the release.