# K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX)

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Dec 19, 2023 after 267 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: 6 generations back to K953076 (1997). 16 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163374: ALLY™ Facet Screws, Providence Medical Technology, Inc. (2017) Summary page 4.

## Most influential descendants
- K232468: SC Medica FFX (2024), 3 descendants of its own
- K252153: FFX Facet Fixation System (2025), 2 descendants of its own
- K240085: zLOCK Lumbar Facet Fixation System (2024), 2 descendants of its own
- K251885: CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (2025), 1 descendant of its own
- K261209: Ion-L (2026), 0 descendants of its own

## Indications for use
PMT Facet Fixation System, Lumbar (PMT FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. PMT FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). PMT FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

Source page: https://510kreport.com/device/K230840
Methodology: https://510kreport.com/methodology