Auxano Medical was granted FDA 510(k) clearance to market its ARKEO wedge fixation system, designed for use in Evans and Cotton osteotomies. ARKEO Wedge integrates an anatomical design with the pillared microstructure of Auxano’s in-growth technology to provide a secure fixation interface at the site of correction.
The system is designed to optimize fixation and graft integration through key features:
Anatomical Fit: Subflush placement reduces irritation and maintains alignment.
Open Architecture: Large central graft cavity and thru-growth fenestrations maximize graft capacity and promote biologic fixation.
Controlled Stability: The unique pillared surface morphology has demonstrated viability in scientific research studies and clinical efficacy in midfoot fusion applications.
Intuitive Instrumentation: Simplifies each step for efficient, consistent outcomes.
Supplied non-sterile in a steam-sterilizable tray, the ARKEO system includes a Hintermann distractor, k-wires, osteotomes, mallet, slap hammer, implant trials, inserter, and an impactor.
“Achieving 510(k) clearance for ARKEO represents a significant advancement in our orthopedic portfolio,” said Joe Harr, Sales & Distribution Manager at Auxano Medical. “This system combines modern engineering with practical, surgeon-focused innovation to deliver reproducible results and improve the surgical experience.”
Auxano Medical was granted FDA 510(k) clearance to market its ARKEO wedge fixation system, designed for use in Evans and Cotton osteotomies. ARKEO Wedge integrates an anatomical design with the pillared microstructure of Auxano's in-growth technology to provide a secure fixation interface at the site of correction.
The system is designed to...
Auxano Medical was granted FDA 510(k) clearance to market its ARKEO wedge fixation system, designed for use in Evans and Cotton osteotomies. ARKEO Wedge integrates an anatomical design with the pillared microstructure of Auxano’s in-growth technology to provide a secure fixation interface at the site of correction.
The system is designed to optimize fixation and graft integration through key features:
Anatomical Fit: Subflush placement reduces irritation and maintains alignment.
Open Architecture: Large central graft cavity and thru-growth fenestrations maximize graft capacity and promote biologic fixation.
Controlled Stability: The unique pillared surface morphology has demonstrated viability in scientific research studies and clinical efficacy in midfoot fusion applications.
Intuitive Instrumentation: Simplifies each step for efficient, consistent outcomes.
Supplied non-sterile in a steam-sterilizable tray, the ARKEO system includes a Hintermann distractor, k-wires, osteotomes, mallet, slap hammer, implant trials, inserter, and an impactor.
“Achieving 510(k) clearance for ARKEO represents a significant advancement in our orthopedic portfolio,” said Joe Harr, Sales & Distribution Manager at Auxano Medical. “This system combines modern engineering with practical, surgeon-focused innovation to deliver reproducible results and improve the surgical experience.”
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