# K253676: CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: May 14, 2026 after 174 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: 8 generations back to K953076 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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.

## Indications for use
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS PCSS 3D 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. CORUS PCSS 3D is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with FDA cleared/approved spine stabilization hardware for anterior cervical fusion at the same level(s). CORUS PCSS 3D 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. CORUS PCSS 3D is to be used with autogenous bone and/or allogenic bone graft.

Source page: https://510kreport.com/device/K253676
Methodology: https://510kreport.com/methodology