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.
Cement Obturator
General, Plastic Surgery
The Cement Obturator (product code LZN) is an orthopedic implant accessory used to seal or block the intramedullary canal with bone cement during joint replacement surgery, ensuring proper cement pressurization and distribution for implant fixation. Regulated under 21 CFR 878.3300 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant given its placement within the bone canal. The device falls under the General and Plastic Surgery specialty with review by the Orthopedic (OR) panel. It is not life-sustaining.
510(k) Clearances
37 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.