Class Class II
SI-Cure Sacroiliac Joint Fusion System (K223819)
Description
SI-Cure Sacroiliac Joint Fusion System by Alevio, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223819
Clearance Date2023-01-18
Clearance TypeSpecial
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223819
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SI-Cure Sacroiliac Joint Fusion System (K223819) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212903 | SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2021 |
| K141106 | FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM | Folsom Metal Products, Inc. Dba Fro... | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232878 | TransLoc 3D | Foundation Fusion Solutions, LLC (D... | 2023 |
| K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023 |
Trace the full predicate network for K223819
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.