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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Orthopedic
The Pediatric Epiphysiodesis Bone Growth Control Plate (product code OBT) is an orthopedic implant used to redirect the angle of growth of long bones in pediatric patients with an open physis, indicated for temporary or permanent epiphysiodesis to gradually correct angular deformities such as valgus, varus, or flexion-extension deformities of the knee, ankle, elbow, or wrist. The device may be removed once growth equalization or physeal fusion is achieved. This device is FDA Class 2 under regulation 888.3030 in the Orthopedic specialty, requiring 510(k) clearance, and is notably flagged as both an implant and as life-sustaining/life-supporting.
510(k) Clearances
6 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.