510(k) · Cleared
Cleared3.8MM CS Facet Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triage Medical, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Oct 17, 2005 as substantially equivalent to K020411 (Nuvasive, Inc., 2002) after an 81-day review. Its family tree reaches back 1 generation to 2002. 27 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 81 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020411 (2002). 27 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- This deviceK052043 3.8MM CS Facet Compression DeviceTriage Medical, Inc. · 2005
- Descendant · cites it directly · 26 of its ownK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- Descendant · 2 generations on · 18 of its ownK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- Descendant · 3 generations on · 10 of its ownK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- Descendant · 3 generations on · 9 of its ownK230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023
- Descendant · 2 generations on · 8 of its ownK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012 · cites it directly26descendants
- K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017 · 2 generations on18descendants
- K211855Ion Facet Screw SystemSurGenTec, LLC · 2022 · 3 generations on10descendants
- K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023 · 3 generations on9descendants
- K183589PMT Facet ScrewProvidence Medical Technology, Inc. · 2019 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| 0 (this device) | K052043 | 3.8MM CS Facet Compression Device | Triage Medical, Inc. | 2005 | — |
| +1 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| +2 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| +3 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| +3 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023 | — |
| +2 | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 1…The 3.8mm CS Facet Compression Device is similar in basic design, materials and intended use to the NuVasive Tm 3.5mm Triad Tm Facet Screw System cleared under 51 0(k) K02041 1. DEVICE DESCRIPTION The 3.8mm CS Facet Compression Device is a double-helix screw with a compression- locking collar, and is p… | 2002 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion.
The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to SI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052043: 3.8MM CS Facet Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052043
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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