# K252153: FFX Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sc Medica
- Decided: Oct 16, 2025 after 99 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 K994308 (2000). 21 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K232468: SC Medica FFX, Sc Medica (2024) Summary page 5.
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX), Providence Medical Technology, Inc. (2023) Summary page 5.

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

## Indications for use
FFX is a lumbar facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the component FFX screw through the component FFX facet cage. 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. FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DOD) 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 from L3 to S1 in skeletally mature patients who have failed conservative care.

Source page: https://510kreport.com/device/K252153
Methodology: https://510kreport.com/methodology