# K250679: FFX Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sc Medica
- Decided: Dec 4, 2025 after 273 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241035: PMT Posterior Cervical Stabilization System (PCSS), Providence Medical Technology, Inc. (2024) Summary page 5.
- K252153: FFX Facet Fixation System, Sc Medica (2025). Cleared while this submission was under review Summary page 5.

## Indications for use
FFX is a facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the components FFX screw through the component FFX facet cage. Please refer to the Instructions for Use for the device size listings intended for cervical and lumbar use. 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 (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 from L3 to S1 in skeletally mature patients who have failed conservative care. FFX is intended to provide temporary fixation and stabilization to the cervical spine as an adjunct to posterior cervical fusion (PCF) through bilateral immobilization of the facet joints and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF), at the same level(s), in up to 3 consecutive levels of the cervical spine (C3-C7). FFX is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. FFX is to be used with autogenous bone and/or allogenic bone graft.

Source page: https://510kreport.com/device/K250679
Methodology: https://510kreport.com/methodology