EDGE gets FDA clearance for VIEW Plating System and REDUCE Fracture Plating System
Published on August 28, 2014 at 9:52 PM
EDGE Orthopaedics, a new entry in the orthopedic medical device space, is excited to announce they have received their second 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 VIEW Plating System utilizes 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 surgeons a wide range of low-profile plate designs to address some of the most common procedures performed by foot and ankle surgeons. 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 REDUCE Fracture Plating 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, utilize the same instrumentation tray for increased hospital efficiency. EDGE's RIVAL Instrumentation provides surgeons with intraoperative flexibility along with saving hospital staff time and money. "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. This can be a game changer for operating rooms," said Anna Kroll, COO.