Medline UNITE, a company focused on the foot and ankle surgery market, has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reflex Hybrid nitinol implant system.

Reflex Hybrid implants merge the compression of a nitinol staple with the stability of a locking plate. It offers indication-specific implants designed for MTP fusions and Lapidus procedures.

When combined with a cannulated screw with a Dynamic Disc, or a Reflex nitinol staple, the construct creates dynamic biplanar compression and fixation for a fully dynamic construct.

The system also features and inserter that lets surgeons expand the implant’s legs for a more streamlined technique. Since both the implant’s legs are on the same joint, there’s flexibility to adjust implant placement, which Medline said isn’t possible with other nitinol solutions on the market.

“Reflex Hybrid further demonstrates our commitment to offering innovative solutions for foot and ankle surgeons,” said Medline UNITE VP of product management Scott Goldstein. “The first to market product addresses gaps in the current competitive landscape, including offering indication specific designs, intraoperative compression, and intraoperative adjustment with a nitinol implant.”

“In addition to speed and efficiency, many surgeons have adopted nitinol staples because they provide dynamic compression after implantation and throughout the healing phase,” added Medline UNITE director of product development Natan Pheil. “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.”

Last month, the company launched its Unite synthetic ligament augmentation implant, which is constructed from an open weave synthetic, non-resorbable material.