Orthopedic surgical device company Meduloc received 510(k) clearance from the FDA for its intramedullary fracture fixation system.
The system is designed to treat small, long bone fractures, combining a flexible nitinol implant with a deployable prong locking mechanism, according to a Nov. 12 news release from Meduloc.
Surgeons using the system have the option to avoid entry through the joint capsule, which can enable earlier mobility, fewer complications, reduced surgical complexity and allow for faster patient recovery.
Indications addressed by the platform include metacarpal, radius, ulna, clavicle and fibula fractures.
With the clearance, Meduloc is preparing for a U.S. commercial launch for the system, the release said.
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