iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R

The iBur™ Hubs and Cutting Accessories are powered surgical drilling instruments designed for bone cutting in neurosurgery, spine surgery, ENT, and endoscopic procedures. They attach to the Stryker CORE® Console with electric or pneumatic motors and perform drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing operations. The devices come in multiple sizes (2.0–5.0 mm) with round and match head configurations.

The subject devices maintain identical technological characteristics to the predicate: SD/PD style motor interface, snap-lock attachment mechanism, 17.1 cm overall length when assembled, angled nose tube, round and match head styles, 2–5 mm diameter sizes, 12.5 cm length, two flutes, integrated polytube irrigation, 2-year shelf life, gamma sterilization, 10⁻⁶ sterility assurance level, 5000–75000 rpm speed capability, and identical materials (M2/440B diamond coat, 316L/440C stainless steel). Two modifications were made: the distal bend profile now commences more proximally with a larger radius for a gradual curve, and alignment specifications were introduced for the cutting accessory distal bushing and nose tube.

ISO 14971 risk management was conducted. Performance testing included temperature and simulated use testing and design validation. No clinical testing was deemed necessary.

The subject devices are substantially equivalent because they maintain identical indications for use, classification, regulatory pathway, and all major technological characteristics as the predicate K210377. The two design modifications—a gentler distal bend profile and introduction of an alignment specification—do not change the fundamental scientific technology or intended use. Risk analysis identified the areas requiring verification, and all acceptance criteria were met in performance testing including temperature testing. These refinements actually reduce distal tip contact pressure without altering how the device cuts bone or interfaces with the motor system, therefore raising no new safety or effectiveness questions.