Medline UNITE has secured the US Food and Drug Administration (FDA) 510(k) approval for its Reflex Hybrid Nitinol Implant System for use in foot and ankle surgery.
The Reflex Hybrid system combines the compression benefits of nitinol staples with the stability of locking plates.
The system is designed for metatarsophalangeal (MTP) fusions and Lapidus procedures.
It features an advanced inserter, allowing surgeons to expand the implant’s legs for a streamlined procedure.
The design places both implant legs on the same side of the joint, offering flexibility in placement, a feature not available in other nitinol solutions.
Reflex Hybrid addresses gaps in the competitive landscape, including indication-specific designs, intraoperative compression, and intraoperative adjustment with a nitinol implant.
Medline UNITE product development director Natan Pheil said: “In addition to speed and efficiency, many surgeons have adopted nitinol staples because they provide dynamic compression after implantation and throughout the healing phase.
“However, staples do not allow the surgeon to achieve compression at the joint prior to deployment of the staple.
“With Reflex Hybrid, the surgeon can drill eccentrically through the implant’s compression ramp and place a non-locking screw to gain additional compression at the joint before deploying the compressive power of the nitinol implant.”
REFLEX implants harness nitinol’s superelastic and shape memory properties, leading the way to new and evolving possibilities, including fully dynamic hybrid fixation constructs.
The comprehensive systems deliver dynamic biplanar compression with indication-specific implants for MTP joint fusions and Lapidus procedures.
Dr Jonathon Backus from the Steadman Clinic tested Reflex Hybrid and cannulated screws against traditional titanium plate and screw, and nitinol staple and screw constructs.
He also received a research grant from Medline for an investigator-initiated study.
Backus said: “Biomechanical testing results showed using a HYBRID implant with a screw provides a statistically significant better load to failure and gapping at failure result than a traditional titanium plate and screw construct.
“Historically, nitinol constructs have not performed better than traditional plate and screw constructs with such testing.”
