Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates

The Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates are titanium alloy bone fixation devices intended for stabilization of fresh fractures, revision procedures, osteotomies, joint fusion, and reconstruction of small bones and bone fragments of the foot. They provide locking screw fixation and are available in multiple sizes and orientations, with the I-Beam variant including an internal beam.

The devices are smaller in width than the primary predicate, manufactured from titanium alloy conforming to ASTM F136, and sold sterile (gamma-sterilized) as single-use. The I-Beam Lapidus Plates include an internal beam extending below the cortical surface and are packaged as a kit with Class I exempt instrumentation, whereas Anatomic plates are packaged standalone. Both variants use locking screw fixation with different packaging configurations (poly/Tyvek pouch or PETG blister tray).

ASTM F382-17 (metallic bone plate bend testing), ISO 11607 (packaging validation and sterilization), AAMI ST72 (endotoxin/LAL testing), ASTM F2052, F2119, F2182, and F2213 (MRI safety testing per FDA guidance), USP <85> and USP <161> (pyrogen limits).

The devices are substantially equivalent to predicates K111253 (Arthrex Distal Extremity Plate System) and K150456 (Arthrex Plates, Screws, and Staples) because they share identical basic design features, intended use, fundamental scientific technology, and sterility approach. Differences such as smaller width, internal beam design, and packaging are considered minor modifications that do not raise different questions of safety or effectiveness.