# K251714: Ion-C

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Jan 16, 2026 after 227 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: 10 generations back to K994308 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220951: PMT Facet Fixation System (PMT FFS), Providence Medical Technology, Inc. (2022) Summary page 5.
- K241416: Ion 3D, SurGenTec, LLC (2024) Summary page 5.
- K243265: Ion 3D, SurGenTec, LLC (2024) Summary page 5.
- K240086: Ion 3D, SurGenTec, LLC (2024) Summary page 5.
- K211855: Ion Facet Screw System, SurGenTec, LLC (2022) Summary page 5.

## Indications for use
The Ion-C System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet joint interspace. The Ion-C is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. The Ion-C is indicated for patients requiring a revision for an anterior pseudoarthrosis at one or two contiguous levels, from C3 to C7. The Ion-C is only intended to be used in combination with an FDA-cleared anterior cervical plate and intervertebral body fusion device implanted at the same level(s). The Ion-C is intended for use with autogenous and/or allogenic bone graft.

Source page: https://510kreport.com/device/K251714
Methodology: https://510kreport.com/methodology