The U.S. FDA has cleared Maxx Orthopaedics’ Freedom PCK Revision Knee System. Maxx tells us the newly cleared implant combines previously-cleared Freedom® Stemmed tibial components with patent-pending femoral components and constrained liners, to create what it claims is one of the most bone conserving, low profile revision knee systems available on the market. Handily this news is being disseminated in advance of AAOS, the world’s most significant annual Orthopaedic bash.
Maxx Orthopaedics says its 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.
Underpinning the Freedom PCK revision system is the Freedom Knee total knee replacement system, specifically engineered for high flexion, bone conservation and advanced component size and fit capabilities. Freedom Knee has U.S. FDA, Drugs Controller General of India (DCGI), European CE Mark, and State Food and Drug Administration P.R. China approvals.
Following the same design philosophy as Maxx’s Freedom Total Knee® primary system, the company tells us its 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.
Source: Maxx Orthopaedics, Inc., PR Web