Extremity Medical External Fixation System

The Extremity Medical External Fixation System is an orthopedic device consisting of circular aluminum rings connected by stainless steel rods, pillars, and struts, with bone anchorage provided by HA-coated half pins and wires. It is indicated for adults and pediatric patients (2 years and older) to treat fractures, osteotomies, limb lengthening, joint arthrodesis, bone transport, Charcot foot reconstruction, and various other orthopedic conditions requiring skeletal stabilization.

Key design differences from the predicate include: (1) polyaxial struts with a locking ball joint (male connection) versus the predicate's universal joint (female connection); (2) HA-coated half pins versus non-HA-coated predicate pins; and (3) longer threaded rod length offerings. All devices use identical materials (stainless steel, hydroxyapatite, aluminum 6061-T6, and plastic) and share the same fundamental principles of temporary implant stabilization via external ring components.

ASTM F1541-17 was used for mechanical testing and engineering analysis of the device components.

Substantial equivalence is established because both the subject device and predicates operate on identical technological principles (temporary bone/joint stabilization via HA-coated pins and external ring frameworks), use the same materials with equivalent mechanical properties, share identical indications for use, and the design differences (ball-joint struts, HA coating, and longer rod lengths) do not introduce different safety or effectiveness issues as demonstrated by mechanical testing per ASTM F1541-17.