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, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
Unknown
This device is a semi-constrained hip prosthesis with metal and ceramic-on-ceramic bearing surfaces, intended for cemented fixation, used in total hip arthroplasty to replace a diseased or damaged hip joint. It is classified as a Class 3 (highest risk) device, requiring Premarket Approval (PMA) from the FDA, reflecting the significant clinical consequences of implant failure in a load-bearing joint. The product code is LPF; no regulation number or specific medical specialty code is on file for this entry. This device carries the implant flag, as it is surgically placed permanently within the body.
No 510(k) clearances found for "LPF". Try a different K-number, product code, or device name.
What 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.