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.
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Orthopedic
The Rod, Fixation, Intramedullary and Accessories, In-Vivo Cured, Light-Activated is an implantable orthopedic device consisting of a polymeric balloon inserted into the medullary canal of long bones for fracture fixation; after insertion, the balloon is infused with a liquid monomer and exposed to light, which polymerizes the monomer to create a hardened, rigid intramedullary fixation structure. It is classified as a Class 2 device under regulation 888.3023, requiring 510(k) premarket notification, and falls within the Orthopedic (OR) medical specialty. The product code is QAD. It is flagged as an implant.
510(k) Clearances
7 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.