FDA Clears Leith Medical’s Foot and Ankle Plating System

Leith Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its One Screw, One Step Foot & Ankle Plating System with Anti-Backout Technology.

“Receiving FDA clearance is very exciting,” stated CEO Tim Leak. “This is the first of many products we are developing with our One screw, One step technology, but for now our primary focus is getting the foot and ankle system into the operating room.”

Historically, surgeons had to choose between either a system that enables compression to the bone or a system that is designed to prevent screw back-out, but both of these are required for optimal results. Contouring to the bone allows a small amount of motion (micro-motion), which facilitates bone healing. Securing the screw fixation to the plate helps prevent catastrophic failure due to screw back-out.

The Leith system addresses critical surgical priorities in a hybrid system: allowing micromotion to stimulate physiologic bone healing, but at the same time, prohibiting any screw backout and fixation failure. The simple design does not require towers or cones to guide insertion of screws, which streamlines the surgical process and increases reproducibility of results. In addition, the screws can be inserted 25 degrees off axis and 50 degrees circumferentially setting it apart from the current market standard that only allow 15-18 degree angles. This extra angulation allows surgeons to better capture bone fragments, creating a more efficient process whereby complicated fracture reductions and fusions can be fixated solidly and with confidence, in their entirety, using a plate construct.

Dr. Arush Angirasa, who specializes in foot and ankle trauma and reconstructive surgery at Southwest Orthopedic Group, commented, “This is a huge leap forward in technology to allow fractures to be fixed in a more effective way.”
 
Leith is launching with four plate systems, each with a low profile design, allowing the screws to sit flush with the bone without prominence regardless of angulation, thereby eliminating soft tissue envelope impingement concerns. The 1st tarsal-metatarsal (Lapidus), lesser tarsal-metatarsal, and 1st metatarsal phalangeal joint systems will be used in the forefoot and midfoot to address acute fractures and reconstructive surgeries while the lateral malleolar fracture plates can be utilized for fixation of a variety of distal fibular fracture patterns. The 510(k) clearance also authorizes Leith to launch several other systems including additional tibial and fibular plating systems, providing a comprehensive ankle portfolio for fracture repair and fusions.

The launch of this novel, patented technology enables lower extremity surgeons to have both compression and fixation using the anti-backout tabs.