Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)

The Bonebridge Osteosynthesis Plating System is a bone fixation device consisting of plates, locking and non-locking screws, and instruments for treating fractures at various anatomical locations. The submission includes three system variants: SALGINA 2.5mm for distal radius fractures, CASCELLA 3.5mm for clavicle fractures and malunions, and LEPORELLO 3.5mm for olecranon and proximal ulna fractures and osteotomies.

The subject devices and predicates share identical materials (stainless steel per ISO 5832-1/ASTM F138-F139, or titanium per ASTM F67/ISO 5832-2), design characteristics including locking and non-locking screw hole accommodation, and similar physical dimensions. The subject device is compatible with screws from predicate devices and uses standard sterilization methods. All materials are biocompatible and corrosion-resistant.

Testing referenced ISO 11137-2 (sterilization validation), ISO 17664 and ISO 17665-1 (steam sterilization), ISO 11607 and ASTM F1980 (packaging), ISO 10993-series (biocompatibility), ASTM F2052-21, F2213-17, F2182-19, F2119-24 (MRI safety), and IEC 62366-1 (usability evaluation).

Static and dynamic mechanical testing demonstrated that each subject plate variant achieved substantially equivalent maximum force and cycle-to-failure performance compared to its respective predicate devices (K240318, K142906, K191848, K082807, K102694, K120070, K073186, K000684). Design verification confirmed compatibility of implants and instruments plus anatomical shape equivalence. MRI safety testing confirmed the devices are MR conditional. No new safety or efficacy issues were identified relative to predicates with the same intended use and target populations.