Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Arrowhead Medical Device Technologies
Arrow-Lok Digital Fusion System, K112675*
Stainless steel, 3-dimensional arrow shape for fixation of osteotomies, arthrodeses and reconstruction in lesser toes

Biomet
Comprehensive Reverse Shoulder - El Humeral Bearings, K113121
Comprehensive Reverse Shoulder Humeral Tray, K113069
Indicated for-primary, fracture or revision total shoulder replacement; modifications to original K080642

BioStructures
Interface Bone Void Filler, K112857
For use in the posterolateral spine when mixed with autograft
Builds upon a previous clearance for use in the extremities and pelvis