Class Class II
HILINE™ Fixation System (K230565)
Description
HILINE™ Fixation System by Globus Medical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230565
Clearance Date2023-04-20
Clearance TypeTraditional
Product CodeOWI
Regulation Number888.3010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230565
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. HILINE™ Fixation System (K230565) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation System | Medicrea International SA | 2022 |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. | 2019 |
| K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 |
| K172417 | SILC® Fixation System | Globus Medical, Inc. | 2017 |
| K153348 | JAZZ LOCK | Implanet, S.A. | 2016 |
| K133482 | SILC FIXATION SYSTEM | Globus Medical, Inc. | 2014 |
| K124058 | CREO STABILIZATION SYSTEM | Globus Medical, Inc. | 2013 |
Trace the full predicate network for K230565
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.