# K242527: The Karma® Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: May 21, 2025 after 268 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K953076 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240085: zLOCK Lumbar Facet Fixation System, Zygofix, Ltd. (2024) Summary page 5.

## Indications for use
The Karma Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.

Source page: https://510kreport.com/device/K242527
Methodology: https://510kreport.com/methodology