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.
Software For Diagnosis/Treatment
Orthopedic
The Software for Diagnosis/Treatment (product code OSN) is orthopedic software associated with trauma devices, intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions. It provides computational tools to support clinical decision-making for orthopedic trauma cases. As an FDA Class 2 device under regulation 888.3030, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. Notably, this software product is flagged as related to implants in its use context, though the software itself is not implanted. It is not life-sustaining.
510(k) Clearances
4 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.