ZKR Orthopedics Takes a Leap Forward as FDA Acknowledges Breakthrough Status for LIFT Implant Innovation
Tuesday, October 10, 2023
ZKR Orthopedics, Inc., a company specializing in medical devices in the clinical stage, proudly announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its groundbreaking LIFT implant technology. This innovative LIFT implant aims to alleviate pain, improve functionality, and potentially delay or even eliminate the necessity for knee replacement surgery.
Upon receiving FDA marketing authorization, the LIFT technology could revolutionize patient care for individuals suffering from advanced cartilage degeneration and osteoarthritis in the patellofemoral compartment of the knee. Moreover, the unique design of the LIFT implant has the potential to enhance the effectiveness of concurrent procedures, such as cartilage grafting and microfracture, for treating patellofemoral cartilage degeneration.
The core of the LIFT implant's innovation lies in its ability to elevate and realign the patella tendon, reducing compressive forces in the patellofemoral compartment and promoting healthier patellar tracking. The comprehensive LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a proprietary positioning instrument. The trial spacers and positioning instrument work together to ensure precise implant size selection and placement beneath the patella tendon. While K-wires temporarily secure the implant, three standard bone screws provide permanent fixation.
Notably, the surgical procedure is designed to be minimally invasive and can be performed in an outpatient setting, highlighting its potential as a significant advancement in patient care.
The coveted Breakthrough Device Designation for the LIFT implant technology underscores the critical need to expand treatment options for patients dealing with knee cartilage degeneration. To secure this designation, ZKR demonstrated the technology's potential for providing a more effective treatment approach for the identified condition in its proposed indications for use.