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.
Condylar Plate Fixation Implant
Orthopedic
The Condylar Plate Fixation Implant is an orthopedic surgical implant used to stabilize and fix fractures or osteotomies at the condylar region of long bones, particularly the femur or humerus, by providing rigid internal fixation. It is classified as FDA Class 2 (moderate risk), meaning it is subject to general controls and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The product code is JDP, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device is flagged as an implant, reflecting its permanent or long-term placement within the body.
510(k) Clearances
2 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.