510(k) · Cleared
ClearedCORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Medical Technology, Inc. · MRW System, Facet Screw Spinal Device
Cleared on May 14, 2026 as substantially equivalent to K241035 (Providence Medical Technology, Inc., 2024) after a 174-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- May 14, 2026
- Review
- 174 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K953076 (1997). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 7 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 6 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 5 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 4 generations backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- 3 generations backK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
- 2 generations backK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
- 1 generation backK241035 PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024
- This deviceK253676 CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −7 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −6 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −5 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −4 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| −3 | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
| −2 | K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022 | — |
| −1 | K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024 | — |
| 0 (this device) | K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241035 | PMT Posterior Cervical Stabilization System (PCSS)Summary page 5…edic and Rehabilitation Devices Panel Predicate Device: PMT Posterior Cervical Stabilization System (PCSS), K241035 Reference Device: iFuse Implant System; iFuse-3D Implant, K162733 P… | 2024 |
| † | K162733 | iFuse Implant System® - iFuse-3D implant | 2017 |
| † | K230297 | PMT Expandable Cage (PMT EXP) | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 2 other devices also cite its predicate K241035.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
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…
Read the full statement (153 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253676: CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253676
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026