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.
Metal Cemented Constrained Femorotibial Knee Prosthesis
Orthopedic
This device is a metal cemented constrained femorotibial knee prosthesis, a fully constrained total knee implant consisting of metal components fixed with bone cement, used in patients requiring knee joint replacement where significant ligamentous instability or deformity precludes less constrained designs. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA). The product code is KRN, regulated under 21 CFR 888.3480 within the Orthopedic specialty. The FDA issued a call for PMAs on December 26, 1996, per 61 FR 50710 (September 27, 1996). This device is designated as an implant.
No 510(k) clearances found for "KRN". 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.