Hoffmann LRF System

The Hoffmann LRF System is a modular, ring-based external fixation system for treating orthopedic conditions of the limbs in pediatric (2-21 years) and adult patients. It uses pins and wires to connect bone to aluminum, carbon fiber, and stainless steel rings that can be statically placed or gradually manipulated for fracture treatment, limb lengthening, deformity correction, and bone reconstruction.

The subject device includes wireless communication and additional hardware components compared to predicates, but maintains the same fundamental ring-based external fixation design and general operating principles. It is manufactured from aluminum, carbon fiber, stainless steel, and polymers, and includes web and mobile applications.

ASTM 1541-2 and ASTM F382 for static and dynamic mechanical testing; IEC 60601-1-2 for electromagnetic compatibility; ANSI C63.27 for wireless coexistence; IEC 60601-1 for electrical safety; and software verification and validation testing.

The Hoffmann LRF System is substantially equivalent to its predicates because it has similar technological characteristics, identical intended use and indications for use, serves the same patient population, and operates on the same principles despite some technological differences in wireless communication features.