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.
Orthopedic Computer Controlled Surgical System
Neurology
The Orthopedic Computer Controlled Surgical System is a robotically-assisted surgical system used for pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision, specifically as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty. Classified as FDA Class 2 under regulation 21 CFR 882.4560 within the Neurology medical specialty and reviewed by the Orthopedic panel, it requires a 510(k) premarket notification. The product code is OJP. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
4 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.