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.
Cranial Distraction System
Neurology
The Cranial Distraction System is a metal implantable device used to establish osteodistraction and bone growth in the skull; bone segments are attached to plates with screws to prevent movement during the distraction process. It falls under the Neurology medical specialty and is classified as a Class 2 device under regulation 882.5330, requiring 510(k) premarket notification. The device is both an implant and life-sustaining, reflecting its role in promoting cranial bone growth in patients with skull abnormalities. General controls and special controls apply.
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.