Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)

The Surgify Halo is a sterile, single-use surgical burr designed to cut and shape bone and hard tissue during neurosurgical, spinal, ENT, and general surgical procedures. It features a ring mechanism in the burr head to reduce chattering and is compatible with standard high-speed surgical drill systems.

The device maintains identical intended use, operating principle, and design configuration to the predicate. It consists of a cylindrical shank with locking features, a burr head with dual cutting edges, and a self-centering ring and spring mechanism that allows the cutting edges to engage or disengage with tissue as needed. Materials meet biocompatibility requirements, and the device is gamma sterilized and single-use.

ISO 11137 for sterilization validation (bioburden re-validation). Testing also included design verification for durability, chattering, and compatibility with drill systems, plus in-process cleaning and passivation validation.

The subject device is substantially equivalent because it shares the same indications for use, environment of use (hospital), operating principle (rotary motion transfer through shank to cutting burr head), and design configuration as predicate K232684. Performance testing confirmed all design input requirements were met, including durability, chatter reduction, and drill system compatibility. The proposed modifications—new model variants with compatible attachments and supplier changes—do not alter safety or effectiveness, as verified through performance data and risk assessment.