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.
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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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Injector, Vertebroplasty (Does Not Contain Cement)
Orthopedic
The Injector, Vertebroplasty (Does Not Contain Cement) (product code OAR) is a Class 1 orthopedic device intended for the injection of vertebroplasty bone cement during vertebroplasty or kyphoplasty procedures for the fixation of pathological vertebral compression fractures resulting from osteoporosis, benign lesions such as hemangioma, or malignant lesions such as metastatic cancers or myeloma. Regulated under 21 CFR 888.4200 within the Orthopedic specialty, it is subject to general controls and exempt from 510(k) requirements but not GMP-exempt. The device carries no implant or life-sustaining flags.
510(k) Clearances
1 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.