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.
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Orthopedic
The Total Anatomic Shoulder Prosthesis with Uncemented Metaphyseal Humeral Stem (Semi-Constrained, No Diaphyseal Incursion) is an orthopedic implant designed for total anatomic shoulder arthroplasty, replacing the humeral head with a metaphyseal-anchored stem that does not extend into the diaphysis, providing fixation without bone cement. It is an FDA Class 2 device regulated under 21 CFR 888.3660, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PKC, and it is flagged as an implant. This device is not life-sustaining.
510(k) Clearances
17 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.