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Auxano® Medical Receives FDA 510(k) Clearance for the ARKEO™ Wedge Fixation System

FOR IMMEDIATE RELEASE

Brecksville, OH – January 28, 2026Auxano® Medical, an innovator in orthopedic implant technology, today announced the launch of ARKEO™, a next-generation wedge fixation system designed to deliver enhanced control, reproducibility, and biologic integration in foot and ankle corrective procedures.

ARKEO™ was engineered with a focus on anatomical fit and surgical precision, pairing Auxano® Medical’s proprietary surface technology with an open, biologically favorable design. The system is intended to provide surgeons with reliable fixation while supporting optimal graft incorporation at the osteotomy site.

“ARKEO™ represents our commitment to solving real surgical challenges with thoughtfully engineered solutions,” said Joe Harr, Sales and Distribution Manager of Auxano® Medical. “From implant architecture to instrumentation, every element of ARKEO™ was designed to help surgeons achieve consistent, confident outcomes.”

Key Features of the ARKEO™ System Include:

  • Anatomical, Subflush Design – Designed to sit subflush to the bone to help minimize soft tissue irritation
  • Enhanced Fixation – Pillared surface morphology intended to support initial stability and long-term fixation
  • Open Architecture – Large central graft window and thru-growth fenestrations maximize graft packing and promote biologic fixation
  • Intuitive Instrumentation – A comprehensive surgical set designed to improve reproducibility and surgeon control

The ARKEO™ system includes dedicated instrumentation such as a Hintermann distractor, trials, inserter, impactor, and accessory implants, all provided non-sterile in a steam-sterilizable tray. The system is indicated for use in Evans and Cotton osteotomies with ancillary plating fixation.

ARKEO™ has received FDA 510(k) clearance for use in internal fixation of bone fractures and osteotomies of the foot and ankle.

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