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.
Screw Sleeve Bone Fixation Device, Spine
Orthopedic
The Screw Sleeve Bone Fixation Device for Spine is an implantable device designed to be used in conjunction with a failed or loosened non-resorbable metallic bone screw in spinal fixation constructs, fitting between the screw threads and surrounding bone to increase surface area, create an interference fit, and restore construct stability. It addresses the clinical challenge of screw backout or loosening in spinal instrumentation. Classified as FDA Class 2 under regulation 888.3043, it requires 510(k) clearance in the Orthopedic specialty and is flagged as an implant. It is not life-sustaining.
510(k) Clearances
2 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.