510(k) · Cleared
ClearedCORUS-LX Implant
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 Nov 20, 2025 as substantially equivalent to K251885 (Providence Medical Technology, Inc., 2025) and 1 other predicate after a 55-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Nov 20, 2025
- Review
- 55 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K953076 (1997). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 5 generations between
- 3 generations backK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
- 2 generations backK241035 PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024
- 1 generation backK251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
- This deviceK253190 CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 8 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 7 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 6 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 5 generations backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- 4 generations backK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
- 3 generations backK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
- 2 generations backK241035 PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024
- 1 generation backK251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
- This deviceK253190 CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −8 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −7 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −6 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −5 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| −4 | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
| −3 | K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022 | — |
| −2 | K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024 | — |
| −1 | K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025 | — |
| 0 (this device) | K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantSummary page 5…thopaedic and Rehabilitation Devices Panel Primary Predicate Device: CORUS-LX Implant (“CORUS-LX”), K251885 Additional Predicate: PMT Facet Fixation System, Lumbar (“PMT FFS-LX”), K230840 A. Device Des… | 2025 |
| * | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX)Summary page 5…CORUS-LX Implant (“CORUS-LX”), K251885 Additional Predicate: PMT Facet Fixation System, Lumbar (“PMT FFS-LX”), K230840 A. Device Description CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide i… | 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 28 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 21 ancestors has a recall of any class.
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. 2025, 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-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…
Read the full statement (171 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253190: CORUS-LX Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253190
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026