APTUS Shoulder Proximal Humerus System, PentaLock 3.5

The APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is a metallic bone fixation system comprising plates, spiral blades, locking screws, and cortical screws used for treating fractures, osteotomies, and non-unions of the proximal humerus. The system is available in sterile and non-sterile configurations with five plate designs for left and right sides, and spiral blades in 50° and 40° angulations.

The primary technological modification from predicate devices is the change from a trilock design to a Pentalock locking mechanism on the screw heads. The device shares the same materials, dimensions, intended use, operating principles, and basic designs as predicate devices K120108 and K181425. All screws feature self-tapping cortical threads with 3.5 mm diameter in lengths ranging from 16-60 mm.

Bench testing included construct testing per K120108 worst-case parameters. PentaLock 3.5 locking and non-locking screws were tested according to ASTM F543 and evaluated against acceptance criteria in the FDA Guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway'.

Substantial equivalence is established because the device has identical intended use and indications as predicate K120108, uses the same operating principles and materials, and incorporates the same basic designs. The Pentalock design modification does not raise new safety or effectiveness questions, as performance testing demonstrates the new devices meet the same acceptance criteria as previously cleared predicate devices.