Extremity Medical External Fixation System

The Extremity Medical External Fixation System is an external fixation device consisting of circular rings, connection elements (rods, pillars, struts), and bone anchorage elements (wires and half pins) made of stainless steel and anodized aluminum. It is indicated for treating fractures, osteotomies, limb lengthening, bone transport, joint arthrodesis, Charcot foot reconstruction, and related orthopedic conditions in patients 2 years and older.

The device uses the same core technological approach as predicates: temporary implants (wires and half pins) fixed to external rings via hardware, with connection elements linking multiple rings. Key design differences include double-row holes with olive wire mounting options on rings, tapped holes on foot rings for direct bolt attachment, and anatomic foot ring options. All components are made of identical materials (stainless steel, aluminum 6061-T6, plastics, rubber) as predicate devices.

ASTM F1541-17 was used for static and dynamic construct testing to evaluate the device's mechanical properties and structural integrity.

The device is substantially equivalent because it shares identical materials, indications for use, and fundamental design principles with predicate devices (Smith & Nephew Ilizarov, Paragon 28 Monkey Rings, and DePuy Synthes Maxframe). The design differences—improved ring hole configurations, tapped holes for bolting, and anatomic options—represent refinements that do not create new safety or effectiveness issues. Engineering analysis and ASTM F1541-17 testing demonstrated mechanical equivalence, and the device performs the same function of temporary external bone stabilization.