FDA clears Able Medical’s Mach screw clip system

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 2 or 4 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 s…

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