Able Medical Devices recently announced that its Mach screw clip system has received FDA 510(k) clearance.
Marquette, Mich.–based Able Medical designed the screw systems as a single-use, sterile screw delivery system that does not require reprocessing or sterilization. It clips directly on to the Valkyrie thoracic fixation system and are pre-loaded with screws that are available in a modular two or four screw configuration.
“The Mach screw clip system is designed to simplify and speed up sternal closure, specifically targeting screw delivery,” Wade DePas, director of quality and product development, said in a news release. “By eliminating the need to go back-and-forth to individually load screws, we’ve removed procedural steps and increased efficiency, thus saving time in the OR and the associated costs.”
The screw clip system also uses a hard shoulder stop to prevent overdriving of screws. The clips can be loaded with Able Medical’s HA nano Bioactive screws to draw osteoblasts up into their threads and speed up osseointegration, according to the company.
“The screws themselves offer an advanced level of bony integration and the system has been overwhelmingly accepted at all our initial Centers of Excellence,” managing director Peter Didyk said.
Able Medical’s Mach screw system is exclusive to the company’s Valkyrie thoracic fixation system, which is used in the stabilization and fixation of fractures of the cheat wall, including sternal fixation and sternal reconstructive surgical procedures.