Maxx Orthopedics announces FDA 510(k) clearance of new Freedom® Titan PCK Revision Knee System and partnership with UNIK Orthopedics, Inc.

FDA 510(k) clearance of new Freedom Titan PCK Revision Knee addresses metal sensitivity in total knee replacement surgery. Strategic partnership with UNIK Orthopedics, Inc. is perfect for Ambulatory Surgery Centers (ASCs) and Hospitals.

NORRISTOWN, Pa., Sept. 3, 2024 /PRNewswire-PRWeb/ — Maxx Orthopedics, Inc. (Norristown, PA.), a rapidly expanding global orthopedics device company, today announces that it received US FDA clearance for the Freedom® Titan PCK Revision Knee System.

In addition, Maxx Ortho has entered into a strategic partnership with Unik Orthopedics (UNIKO), Inc. (San Jose, CA), a company focused on highly advanced personalized medical devices, robotics, and medical software for joint replacement procedures.

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, multi-radius femoral design, patented trapezoidal box, and titanium stems, augments and couplers. Titan PCK has a unique golden color on the femoral and tibial components from the titanium niobium nitride (TiNbN) coating produced by a physical vapor deposition (PVD) process. The strong TiNbN coating has been shown to block or significantly reduce the release of metal ions common in orthopedic joint replacement implants.

Titan PCK System demonstrates our ongoing pursuit of knee arthroplasty solutions that address needs in total joint replacement, especially the 10-15% of the population with metal sensitivity. Farzin Khaghani, Chief Commercial Officer, states “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. We are thrilled to offer our distinct Titan knee portfolio to osteoarthritis patients dealing with challenges associated with metal sensitivity.”

Maxx Orthopedics has established a partnership with Unik Orthopedics (UNIKO) to offer personalized surgical instrument blocks for total knee arthroplasty.

UNIKO recently received FDA 510(k) clearance for PointCloud™ Knee Instrument intended for use in surgery to assist with intraoperative implant placement and as a guide for bony resections during total knee replacements. Preoperative MRI scans are obtained during the Pre-Op planning process and used to identify anatomic landmarks necessary for alignment and positioning of the implant 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. Combining the UNIKO PointCloud with our Quick Recovery Solutions (QRS®) platform, offers a perfect blend of complementary technologies and an efficient, cost-effective solution for ambulatory surgery centers and hospitals.

The PointCloud Knee Instruments allow surgeons to have patient-specific, CNC machined solid block (Acetal-C), single-use instruments during surgery. Surgeons will be able to precisely template PSI blocks during pre-operative planning and recommend patient-specific component sizing. “Dr. Kurtis Biggs (Naples, FL) 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, states Anand Bala, Vice President of Product.

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

About Maxx Orthopedics, Inc.

Maxx Orthopedics, Inc. is the manufacturer of the Freedom Knee System, Libertas Total Hip System, and Quick Recovery Solutions (QRS). We develop and market innovative orthopedic medical devices with a focus on providing state-of-the-art implants and related solutions designed that best restore patient mobility, while accommodating lifestyle, anatomical and economic needs. Find out more at www.maxxortho.com and follow us on LinkedIn, X, Instagram, and Facebook.

About UNIK Orthopedics, Inc.

For information, please visit https://unikortho.com/.

Media contacts:

Maxx Orthopedics, Inc. Unik Orthopedics, Inc.

Donald Montgomery Charlie Chi ,Ph.D., Founder & CTO

info@maxxortho.com charlie@unikorthopedics.com

Media Contact

Donnie Montgomery, Maxx Orthopedics, 1 484-392-0092, info@maxxortho.com, www.maxxortho.com

SOURCE Maxx Orthopedics