Sam Brusco, Associate Editor10.10.23
ZKR Orthopedics, a clinical-stage company, has gained Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its LIFT implant.
The LIFT implant was engineered to decrease pain, improve function, and delay or remove the need for knee replacement surgery. The company said its approval with expand the continuum of care for patients with later-stage cartilage degeneration and osteoarthritis (OA) of the knee’s patellofemoral compartment. Its design could also boost effectiveness of concomitant cartilage grafting and microfracture to treat patellofemoral cartilage degeneration.
The implant elevates and realigns the patella tendon, unloading the patellofemoral compartment by reducing compressive forces and shifting patellar tracking toward healthier cartilage. The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a positioning instrument.
The company said the trial spacers and positioning instrument facilitate ideal implant size selection and positioning under the patella tendon. The implant is temporarily held in place by the K-wires, and permanent fixation occurs using three standard bone screws. The procedure was designed to be minimally invasive, as well.
ZKR expects to complete two-year follow-up data from LIFT’s first-in-human trial this month, then submit a pivotal clinical trial application to the FDA by the year’s end. The pivotal trial will be conducted under an investigational device exemption (IDE) and will compare LIFT’s results to patients undergoing a tibial tubercule osteotomy.
The company expects to begin trial enrollment in 2024 in both the U.S. and Europe.
"We very much appreciate the Breakthrough Device Designation from the FDA. The accelerated regulatory review will likely shorten the time to market allowing expanded options for patients suffering from patellofemoral osteoarthritis. Our hope is to improve both pain and function before the onset of comorbidities associated with a sedentary lifestyle," ZKR Orthopedics’ CEO David Cash told the press.
The LIFT implant was engineered to decrease pain, improve function, and delay or remove the need for knee replacement surgery. The company said its approval with expand the continuum of care for patients with later-stage cartilage degeneration and osteoarthritis (OA) of the knee’s patellofemoral compartment. Its design could also boost effectiveness of concomitant cartilage grafting and microfracture to treat patellofemoral cartilage degeneration.
The implant elevates and realigns the patella tendon, unloading the patellofemoral compartment by reducing compressive forces and shifting patellar tracking toward healthier cartilage. The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a positioning instrument.
The company said the trial spacers and positioning instrument facilitate ideal implant size selection and positioning under the patella tendon. The implant is temporarily held in place by the K-wires, and permanent fixation occurs using three standard bone screws. The procedure was designed to be minimally invasive, as well.
ZKR expects to complete two-year follow-up data from LIFT’s first-in-human trial this month, then submit a pivotal clinical trial application to the FDA by the year’s end. The pivotal trial will be conducted under an investigational device exemption (IDE) and will compare LIFT’s results to patients undergoing a tibial tubercule osteotomy.
The company expects to begin trial enrollment in 2024 in both the U.S. and Europe.
"We very much appreciate the Breakthrough Device Designation from the FDA. The accelerated regulatory review will likely shorten the time to market allowing expanded options for patients suffering from patellofemoral osteoarthritis. Our hope is to improve both pain and function before the onset of comorbidities associated with a sedentary lifestyle," ZKR Orthopedics’ CEO David Cash told the press.