510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Ankle Fusion Cage
Orthopedic
An ankle fusion cage is an orthopedic implant intended for use as an accessory to a tibiotalocalcaneal intramedullary rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty; it is not intended for standalone use. It is classified as FDA Class II (510(k) required) under regulation 888.3020 in the Orthopedic specialty, with product code SAI. The device is flagged as an implant, reflecting its permanent placement in the body, though it is not life-sustaining.
510(k) Clearances
2 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.