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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Orthopedic
The Patellofemorotibial Knee Prosthesis (Semi-Constrained, Cemented, Polymer+Additive/Metal/Polymer+Additive) is a total knee replacement implant system used for painful and disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments, and also for correcting varus, valgus, or posttraumatic deformity, or revising failed prior procedures; it is intended for cemented fixation only. Classified as FDA Class 2 under regulation 21 CFR 888.3560 within the Orthopedic medical specialty, it requires a 510(k) premarket notification. The product code is OIY. It is flagged as an implant device.
510(k) Clearances
12 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.