SternalPlate Expansion

The SternalPlate Expansion is a metallic bone fixation device indicated for stabilization and fixation of anterior chest wall fractures, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive procedures. The device consists of four new plate designs (T-Plates and Transverse Plates) that expand the existing SternalPlate System product line.

The new Subject Device plates are geometrically derived from predicate plates (Ladder Plate Narrow and Straight 24-hole Plate) and share identical features, tolerances, and materials. A key difference is that the Subject Device plates can be fixated laterally to the sternum, whereas original predicate plates could not. Manufacturing processes remain unchanged from the predicate device.

ISO 10993-1:2018 for biocompatibility evaluation. Performance bench testing used well-established test methods previously reviewed by FDA in submission K183172, including plate stiffness and strength testing.

Substantial equivalence is established because the four new plates are geometric derivatives of already-cleared predicate plates with the same material composition, tolerances, and manufacturing process. Although the new plates add the capability for lateral sternal fixation, bench testing demonstrated that strength and stiffness meet acceptance criteria compared to additional predicates (DePuy Synthes K190963 and KLS Martin K153482), raising no new safety or effectiveness questions. The indications for use remain unchanged, and biocompatibility poses no new risks.