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, Ptfe/Carbon-Fiber
General, Plastic Surgery
A PTFE/carbon-fiber prosthesis is a surgically implanted synthetic material device used in soft tissue or reconstructive surgery, made from polytetrafluoroethylene (PTFE) and carbon fiber, offering structural support and biocompatibility for applications such as tendon replacement or augmentation. It is classified as an FDA Class 2 device, representing moderate risk, and requires 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. Product code KDA is regulated under 21 CFR 878.3500 in the General, Plastic Surgery medical specialty. This device is flagged as an implant, indicating it is intended to be placed inside the body.
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.