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.
Prosthesis, Ankle, Uncemented, Non-Constrained
Unknown
The Uncemented Non-Constrained Ankle Prosthesis is a surgically implanted total ankle replacement device intended to replace a diseased or damaged ankle joint. It features a tibial component made of cobalt-chromium-molybdenum alloy and a talar component of ultra-high molecular weight polyethylene, with minimal constraint allowing near-normal translation. As an FDA Class 3 device requiring Premarket Approval (PMA), it is subject to the most stringent regulatory pathway. The product code is NTG, reviewed by the Orthopedic panel, and it is flagged as both an implant and a life-sustaining support device.
No 510(k) clearances found for "NTG". 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.