Table 1.

FDA device classes

FDA device class	Examples	Regulatory controls
Class I (low risk)	Bone tamp, screw driver, rongeur, cast saw, compression device	General controls (most are exempt from 510(k) Premarket Notification)
Class II (moderate risk)	Intramedullary nails, ORIF plates, screws, arthroplasty components, spinal fixation implants, vertebral body replacements, bone void fillers	General controls, 510(k) Premarket Notification (few are exempt)
Class III (high risk)	Alternative bearing THA systems, hip resurfacing systems, mobile bearing TKA systems, total ankle replacements, total disc replacements	General controls, Premarket Approval (few are exempt)

ORIF = open reduction internal fixation.