# K230297: PMT Expandable Cage (PMT EXP)

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Aug 11, 2023 after 190 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 K953076 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220951: PMT Facet Fixation System (PMT FFS), Providence Medical Technology, Inc. (2022) Summary page 4.
- K163374: ALLY™ Facet Screws, Providence Medical Technology, Inc. (2017) Summary page 4.

## Indications for use
PMT Expandable Cage (PMT EXP) is an integrated construct comprised of a CAVUX Cage-E and a single ALLY Screw-E. PMT EXP is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT EXP is intended for temporary stabilization as an adjunct to single level posterior cervical fusion in skeletally mature patients. PMT EXP is only intended for use with a single level anterior cervical fusion at the same spinal level that utilizes FDA cleared/approved spine stabilization hardware for anterior cervical fusion procedures. PMT EXP is indicated for the treatment of patients with cervical degenerative disc disease (DDD) with radiculopathy from C3-C7. PMT EXP is indicated for use with autogenous and/or allogenic bone graft.

Source page: https://510kreport.com/device/K230297
Methodology: https://510kreport.com/methodology
