# K243265: Ion 3D

- Pathway: 510(k) (Special)
- Applicant: SurGenTec, LLC
- Decided: Dec 4, 2024 after 50 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). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241416: Ion 3D, SurGenTec, LLC (2024) Summary page 5.
- K211855: Ion Facet Screw System, SurGenTec, LLC (2022) Summary page 5.

## Most influential descendants
- K251714: Ion-C (2026), 0 descendants of its own

## Indications for use
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis Spondylolysis Pseudoarthrosis or failed previous fusions which are symptomatic Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

Source page: https://510kreport.com/device/K243265
Methodology: https://510kreport.com/methodology