DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro

This submission covers seven orthopedic bone fixation devices: DynaNail Mini and Hybrid (fusion nails for foot/ankle fractures and reconstructions), DynaNail Helix (threaded bone fastener for foot/ankle procedures), and DynaClip variants (bone staples for hand, foot, and proximal tibial fixation). All are metallic implants manufactured from titanium alloy or nickel-titanium, used for internal fixation of bone fractures, osteotomies, and joint fusions.

The proposed devices maintain identical technological and performance characteristics to their predicate devices with no design changes. They use the same materials (titanium alloy Ti6Al-4V ELI and nickel-titanium alloy), sterilization methods, and manufacturing processes. The only change is the addition of an 'MR Conditional' labeling claim for magnetic resonance compatibility.

MR Testing per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 were conducted to establish the MR Conditional status. Biocompatibility, sterility, shelf life, packaging, and mechanical performance evaluation leveraged testing equivalent to predicate devices.

The devices are substantially equivalent because they maintain the same fundamental design, intended use, materials, and performance characteristics as their respective predicates. Non-clinical MR testing per ASTM standards supports the MR Conditional claim addition, which does not raise new safety or effectiveness questions. Manufacturing and materials are identical to predicates that were previously cleared.