enHAnce PEEK Bunion System

The enHAnce PEEK Bunion System is a single-use bone fixation device permanently implanted to correct bunions and hallux valgus by fixing the first metatarsal. It consists of a plate and 3.0 mm diameter pins made from HA Enhanced PEEK material, allowing intramedullary insertion with fixation via pins at both proximal and distal ends.

The device uses HA enhanced PEEK material for both plate and pins, similar to predicates K211650, K250646, and K192356. It features a plate with four pin-receiving holes, a stem portion for intramedullary insertion, and dimensions falling within predicate ranges. Design incorporates angled plate features and pin-receiving holes equivalent to cleared predicates.

ASTM F382-24 four-point static and fatigue bend testing was conducted against predicates. Testing also included engineering analysis, dynamic bending, pushout tests, and axial insertion tests per recognized consensus standards and current industry practice.

The device has identical indications for use as predicates, equivalent technological characteristics, and HA enhanced PEEK material matching cleared devices. Engineering analysis and testing demonstrate the enHAnce system does not raise new safety or efficacy issues and does not create a worst-case scenario relative to predicate devices, confirming substantial equivalence in mechanical performance.