# K253190: CORUS-LX Implant

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Nov 20, 2025 after 55 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 K953076 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251885: CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant, Providence Medical Technology, Inc. (2025) Summary page 5.
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX), Providence Medical Technology, Inc. (2023) Summary page 5.

## Indications for use
CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX is placed through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. CORUS-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 (PSR) implanted at the same spinal level(s) to achieve bilateral posterior stabilization. The CORUS-LX is intended to be used as part of bilateral posterior fixation that is achieved either with bilateral placement of CORUS-LX Implants or unilateral placement of the CORUS-LX Implant with PSR on the contralateral side. CORUS-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/K253190
Methodology: https://510kreport.com/methodology