12 Aug Able Medical Announces FDA 510K Clearance for the MACH™ Screw Clip System
The MACH system, a pre-loaded screw system, clips onto the Valkyrie™ Thoracic Fixation System
MARQUETTE, Mich.–(BUSINESS WIRE)–Able Medical Devices announces that the MACH™ Screw Clip System has been granted 510k clearance by the FDA.
The MACH Screw Clip System is a single-use, sterile screw delivery system that does not require reprocessing or sterilization. By clipping directly onto the Valkyrie™ Thoracic Fixation System, the MACH Screw Clip delivers screws extremely fast and accurately for thoracic fixation. The clips are pre-loaded with screws and 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,” said Wade DePas, director, quality & product development for Able Medical. “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 O.R. and the associated costs.”
The MACH Screw Clip System also incorporates other technological advantages such a as a hard shoulder stop, which prevents overdriving of screws and ensures a flush screw-to-plate interface. The clips can also be loaded with Able Medicals HAnano Bioactive screws. These modified screws draw osteoblasts up into their threads and speed up osseointegration.
“The screws themselves offer an advanced level of bony integration and the system has been overwhelmingly accepted at all our initial Centers of Excellence,” said Peter Didyk, managing director of Able Medical.
The MACH Screw Clip System is used exclusively with the Valkyrie Thoracic Fixation System. The Valkyrie system is used in the stabilization and fixation of fractures of the chest wall, including sternal fixation following sternotomy as well as sternal reconstructive surgical procedures for patients with normal and/or poor bone.
About Able Medical
Able Medical Devices is a subsidiary of J.M. Longyear and a leader in cardiothoracic products and contract manufacturing. Able Medical partners with companies seeking first class, outsourced services from design & development to comprehensive finished goods manufacturing. The company’s extensive expertise includes working with surgeons and OEMs in spine, trauma and cardiothoracic markets. Able Medical specializes in developing full surgical systems as well as custom instrumentation. The MACH Screw Clip System and Valkyrie™ Thoracic Fixation System are trademarks of Able Medical.
For more information, see www.ablemedicaldevices.com.
Product Manager – Cardiothoracic
SOURCE: Business Wire, 11th August 2021