Class Class U
The Karma® Fixation System (K242527)
Description
The Karma® Fixation System by Spinal Elements, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK242527
Clearance Date2025-05-21
Clearance TypeTraditional
Product CodeMRW
FDA Database
View on FDA DatabasePredicate lineage for K242527
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. The Karma® Fixation System (K242527) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240085 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024 |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | 2019 |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018 |
Trace the full predicate network for K242527
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.