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.
Growing Rod System- Magnetic Actuation
Orthopedic
The Growing Rod System with Magnetic Actuation is an orthopedic implant device used to stabilize or correct spinal deformities without fusion, uniquely featuring non-invasive magnetic adjustment of the spinal rod to accommodate patient growth over time. It is an FDA Class 2 device regulated under 21 CFR 888.3070, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PGN, and it is flagged as an implant. The magnetic actuation mechanism eliminates the need for repeated surgical procedures to adjust rod length.
510(k) Clearances
9 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.