# K232468: SC Medica FFX

- Pathway: 510(k) (Traditional)
- Applicant: Sc Medica
- Decided: May 9, 2024 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: 7 generations back to K994308 (2000). 20 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 24 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). Cleared while this submission was under review Summary page 4.
- K211855: Ion Facet Screw System, SurGenTec, LLC (2022) Summary page 4.

## Most influential descendants
- K252153: FFX Facet Fixation System (2025), 2 descendants of its own
- K261209: Ion-L (2026), 0 descendants of its own
- K250679: FFX Facet Fixation System (2025), 0 descendants of its own

## Indications for use
SC Medica FFX is a lumbar facet device that is placed bilaterally through a posterior surgical approach and spans the facet interspace. SC Medica FFX must be used with an FDA-cleared transfacet screw cleared for use in the lumbar spine. SC Medica FFX is intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. SC Medica FFX must be accompanied with an FDA-cleared intervertebral body fusion device and/or with an FDA-cleared posterior lumbar pedicle screw and rod system implanted at the same spinal level(s) as an adjunct to a single or two-level intervertebral body or posterolateral fusion, respectively. SC Medica FFX 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.

Source page: https://510kreport.com/device/K232468
Methodology: https://510kreport.com/methodology