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.
Orthopaedic Surgical Planning And Instrument Guides
Orthopedic
The Orthopaedic Surgical Planning and Instrument Guides are surgical instruments designed to assist in pre-operative planning and/or guiding the marking of bone and guiding surgical instruments during orthopedic procedures. They fall under the Orthopedic medical specialty and are classified as a Class 2 device under regulation 888.3030, requiring 510(k) premarket notification. These guides are subject to general controls and special controls to ensure their accuracy and safety in surgical settings. They are not implants and are not life-sustaining.
510(k) Clearances
22 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.