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.
Fastener, Fixation, Biodegradable, Hard Tissue
Unknown
The biodegradable hard tissue fixation fastener is an orthopedic implant used to fix or stabilize bony fragments or structures, designed to degrade and be resorbed by the body over time, eliminating the need for hardware removal surgery. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MBJ and it carries an implant flag; no regulation number or formal medical specialty has been assigned. It does not sustain life.
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.