# K261209: Ion-L

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Jun 11, 2026 after 59 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: 9 generations back to K994308 (2000). 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)
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX), Providence Medical Technology, Inc. (2023) Summary page 5.
- K252153: FFX Facet Fixation System, Sc Medica (2025) Summary page 5.

## Indications for use
The Ion-L System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet interspace. Ion-L is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care. Ion-L is intended to provide temporary stabilization as an adjunct to a 1-level interbody lumbar fusion. The Ion-L is intended to be used with an FDA-cleared intervertebral body fusion device implanted at the same level. The Ion-L is intended for use with autogenous and/or allogenic bone graft.

Source page: https://510kreport.com/device/K261209
Methodology: https://510kreport.com/methodology