UniBur

The UniBur is a single-use, sterile surgical device designed for cutting, drilling, removal, and shaping of bone in neurosurgery, spine surgery, and ENT procedures. It connects to the slim motor handpiece of the Primado2 Total Surgical System and consists of a rotating bur with diamond coating available in 22 product variations differing in length, bur guard angle, bur diameter (0.6–4.5 mm), and diamond grit size.

The UniBur integrates the bur and attachment as a single sterile product, eliminating the separate reusable attachment and single-use bur design of the predicate. Key differences include: lower maximum rotation speed for two models (10,000 vs. 80,000 min⁻¹), no bur attachment/detachment mechanism (supplied sterile, single-use), no adjustable bur length mechanism, and no lubrication requirement. Materials include diamond, nickel, stainless steel, phosphor bronze, FKM, polyamide, and PTFE.

ISO 10993-1:2018 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 GPMT (sensitization), ISO 10993-23 (intracutaneous reactivity), ISO 10993-11 (acute systemic toxicity), USP <151> (pyrogenicity), ASTM F756:2017 (hemolysis), and ISO 11137-2:2013 (sterilization validation).

The UniBur shares the same intended use (bone cutting, drilling, removal, shaping in neuro/spine/ENT surgery), operational principle (rotational motion from electric motor), regulatory class (Class II), and patient population as the predicate P300 Attachment. Although the UniBur consolidates separate attachment and bur components into one sterile device and lacks certain features (adjustable length, bur attachment mechanism, lubrication), these differences are minor design choices that do not affect safety or effectiveness. The reference device (MR8 ClearView Tools) shares these same absent features, demonstrating that single-use integrated design with fixed geometry is an established predicate design. Biocompatibility and sterilization testing confirm compliance with applicable standards, and the bur characteristics (materials, sizes, diamond coatings) remain within the predicate's ranges.