# K241035: PMT Posterior Cervical Stabilization System (PCSS)

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Jun 25, 2024 after 70 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). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 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.

## Most influential descendants
- K251885: CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (2025), 1 descendant of its own
- K253676: CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (2026), 0 descendants of its own
- K250679: FFX Facet Fixation System (2025), 0 descendants of its own
- K253190: CORUS-LX Implant (2025), 0 descendants of its own

## Indications for use
PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. PMT PCSS is intended as an adjunct to posterior cervical fusion (PCF), and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s). PMT PCSS 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. PMT PCSS is to be used with autogenous bone and/or allogenic bone graft.

Source page: https://510kreport.com/device/K241035
Methodology: https://510kreport.com/methodology