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.
Vertebroplasty Compound, Calcium Based
Orthopedic
The Calcium-Based Vertebroplasty Compound is a resorbable bone void filler indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The device resorbs over time and is replaced with new bone during the healing process. It is an FDA Class 2 implant regulated under 21 CFR 888.3027 in the Orthopedic specialty, with product code NUD, requiring 510(k) clearance. The implant flag is set reflecting its surgical placement within the vertebral body. It does not carry life-sustaining support designation.
No 510(k) clearances found for "NUD". Try a different K-number, product code, or device name.
What 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.