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.
Orthopedic Augmented Reality
Neurology
An orthopedic augmented reality device provides visual guidance during orthopedic procedures using stereotaxic navigation, displaying augmented reality stereoscopic images to intraoperatively augment the surgeon's field of view for improved procedural accuracy. It is classified as FDA Class II (510(k) required) under regulation 882.4560 in the Neurology specialty (reviewed by the Orthopedic panel), with product code SBF. The device is not an implant and does not support life-sustaining functions.
510(k) Clearances
42 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.