Orthopedic— FDA advisory panel OR

Orthopedic is one of the heaviest 510(k) panels, and unusually implant-rich for the clearance pathway: hip and knee arthroplasty components, spinal fusion hardware (pedicle screws, interbody cages, plates), bone fixation screws and plates, intramedullary nails, and the large families of manual surgical instruments that support them. Unlike cardiology, where the flagship implants route through PMA, a large share of orthopedic implants clear via 510(k) on substantial-equivalence arguments that trace back decades — which makes this panel a productive place to study long predicate lineages.

The panel's data rewards company-level reading. Orthopedic manufacturers tend to file in clusters — a new fixation system arrives as a coordinated set of clearances for screws, plates, instruments, and sometimes navigation adapters — so a burst of filings under one applicant usually signals a platform launch rather than unrelated products.