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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Patient Specific Manual Navigation System
Neurology
The Patient Specific Manual Navigation System (product code OSE) is a surgical planning and guidance device intended for defining implant alignment relative to a patient's individual anatomy. It is a manual, patient-specific system used during orthopedic procedures to improve placement accuracy. As an FDA Class 2 device under regulation 882.4560, it requires 510(k) premarket clearance, falls within the Neurology specialty by classification, and is reviewed by the Orthopedic panel. The device is not an implant itself and is not life-sustaining.
No 510(k) clearances found for "OSE". Try a different K-number, product code, or device name.
What 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.