Edge Orthopaedics Earns Second 510(k)

Boonton, N.J.-based Edge Orthopaedics has earned its second U.S. Food and Drug Administration (FDA) 510(k) clearance for the View plating system and Reduce fracture plating system.

The View plating system includes anatomic plates used to support multiple indications within the mid-foot. The system includes titanium alloy, sterile packaged lapidus, first metatarsophalangeal (MTP), calcaneal-cuboid (CC), talonavicular (TN) and Evans plates along with sterile titanium alloy locking and non-locking bone screws. The system uses a perimeter loading design that loads areas where healing needs to occur. The design also creates a “window” offering a continuous view into the healing process.

The Reduce fracture plating system offers a range of low-profile plate designs to address some of the most common procedures performed by foot and ankle surgeons. According to the company, the plating system versatility and low-profile anatomic contours allow surgeons to choose the optimal plate and screw configuration to best match patients’ anatomy. The system includes titanium alloy, sterile packaged T, L, Y and straight plates along with the same sterile titanium alloy bone screws used with the View plating system.

Both plating systems and Edge’s Bite compression screws use the same instrumentation tray designed for for increased hospital efficiency.

“By sterile packaging implants and offering one instrumentation tray for multiple product lines, it not only reduces the amount of trays that need to be sterilized and wrapped for a case but it also provides each surgeon the opportunity to change implant needs at a moment’s notice,” said chief operations officer Anna Kroll. “This can be a game changer for operating rooms.”

Edge Orthopaedics makes extremity orthopedics devices.