Trends in Orthopedic Device Innovation: An Analysis of 510(k) Clearances and Premarket Approvals From 2000 to 2019

The objective of this study was to characterize recent trends in orthopedic device development across different subspecialty areas. Orthopedic 510(k) clearances, premarket approvals (PMAs; together, “authorizations”), and new market entrants from 2000 to 2019 were analyzed as markers of research and development activity. Data were extracted from the US Food and Drug Administration website and stratified into one of 9 “subspecialty” groups: spine, trauma, hip arthroplasty, knee arthroplasty, shoulder, hand/ elbow, foot/ankle, cement/filler/graft, and other. Descriptive statistics were used to analyze the data. Growth rates were calculated from trailing 3-year averages. During the study period, there were 9906 orthopedic 510(k) clearances and 1409 PMAs, of which 61 were for original PMA submissions. The preponderance of 510(k) clearances were for devices used in spine (36%) and trauma (30%) surgery, followed by hip (11%) and knee (8%) arthroplasty. Annual 510(k) clearances for spine and trauma devices grew by 232% and 44%, respectively, whereas annual hip and knee arthroplasty clearances declined. Paralleling these findings, the influx of new manufacturers of orthopedic devices was greatest for the trauma surgery (438), spine surgery (383), and cement/filler/graft (181) markets. Spinal surgery and orthopedic trauma have become leading priorities in orthopedic product development during the past two decades. Meanwhile, hip and knee arthroplasty products have proportionally become a smaller category of new devices over time.