FDA Clears Maxx Orthopedics’ Revision Knee System

Maxx Orthopedics Inc. has gained U.S. Food and Drug Administration (FDA) clearance for the Freedom Titan PCK Revision Knee System and is partnering with Unik Orthopedics on personalized surgical instrument blocks.
 
The Freedom Titan PCK Revision Knee System maintains the same advanced, clinically proven design as the Freedom PCK Revision Knee System, featuring progressive constraint kinematics, a multi-radius femoral design, a patented trapezoidal box, and titanium stems, augments, and couplers. Titan PCK has a golden color on the femoral and tibial components from the titanium niobium nitride (TiNbN) coating produced by a physical vapor deposition (PVD) process. The TiNbN coating has been shown to block or significantly reduce the release of metal ions common in orthopedic joint replacement implants, according to the company.
 
The Titan PCK System reflects Maxx Orthopedics’ pursuit of knee arthroplasty solutions that address needs in total joint replacement, particularly the 10% to 15% of the population with metal sensitivity. “The FDA clearance of Freedom Titan PCK System further demonstrates our commitment to developing a strong product pipeline that broadens our portfolio, drives growth, and addresses the needs of a diverse patient population,” Maxx Orthopedics Chief Commercial Officer Farzin Khaghani stated. “We are thrilled to offer our distinct Titan knee portfolio to osteoarthritis patients dealing with challenges associated with metal sensitivity.”
 
Maxx Orthopedics is teaming up with Unik Orthopedics in order to offer personalized surgical instrument blocks for total knee arthroplasty.
 
UNIKO recently received FDA 510(k) clearance for its PointCloud Knee Instrument, which is intended for use in surgery to help with intraoperative implant placement and as a guide for bony resections during total knee replacements. Preoperative MRI scans are obtained during the pre-operative planning process and used to identify anatomic landmarks necessary for implant alignment and positioning during the procedure.
 
UNIKO PointCloud Knee Instruments (UKI) and the Vault System (web-based surgical planning tool) are compatible with the Freedom Total Knee System. Maxx Orthopedics executives said combining the UNIKO PointCloud with the firm’s Quick Recovery Solutions (QRS) platform offers an ideal blend of complementary technologies and an efficient, cost-effective solution for ambulatory surgery centers and hospitals.
 
The PointCloud Knee Instruments enable surgeons to use patient-specific, CNC machined solid block (Acetal-C), single-use instruments during procedures. Surgeons can precisely template PSI blocks during pre-operative planning and recommend patient-specific component sizing. “Dr. Kurtis Biggs (Naples, Fla.) recently performed the first Freedom Primary Knee procedure in the United States using the new UNIK Ortho PSI blocks. Our partnership with UNIKO should increase efficiency for total knee arthroplasty within outpatient surgery centers and hospitals. We are excited to offer QRS, Freedom Knee System, and PointCloud technologies together for the benefit of both patients and surgeons,” Maxx Orthopedics Vice President of Product Anand Bala said.
 
Maxx Orthopedics manufactures  the Freedom Knee System, Libertas Total Hip System, and Quick Recovery Solutions (QRS). The Norristown, Pa.-based firm develops and markets orthopedic medical devices with a focus on providing implants and related solutions that best restore patient mobility, while accommodating lifestyle, anatomical, and economic needs. 

San Jose, Calif.-headquartered Unik Orthopedics Inc. develops advanced personalized medical devices, robotics, and medical software for joint replacement procedures.

References
¹ Serro et al. (2009) A Comparative Study of Titanium Nitrides, TiN, TiNbN and TiCN, as Coatings for Biomedical Applications. Surface & Coatings Technology 203 (2009), pp. 3701–3707