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.
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
Orthopedic
The Shoulder Spacer for Massive Irreparable Rotator Cuff Tear (Resorbable, Inflatable, Non-Fixed) is an orthopedic implant intended to act as a temporary spacer creating a physical barrier between tissues in the shoulder for the treatment of massive irreparable rotator cuff tears, accommodating joint mechanics while the body's healing response is supported. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 888.3630 in the Orthopedic specialty. It carries product code QPQ, is flagged as an implant, and is not life-sustaining.
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.