510(k) · Cleared
ClearedNuvasive Triad Facet Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Mar 12, 2002 after a 33-day review. The FDA summary names its predicate without a number. 48 later devices descend from it.
- Decided
- Mar 12, 2002
- Review
- 33 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 11 citing it directly.
- This deviceK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- Descendant · cites it directly · 29 of its ownK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- Descendant · cites it directly · 27 of its ownK052043 3.8MM CS Facet Compression DeviceTriage Medical, Inc. · 2005
- Descendant · 2 generations on · 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 · cites it directly · 11 of its ownK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K092568Spartan S3 Facet SystemAmendia, Inc. · 2009 · cites it directly29descendants
- K0520433.8MM CS Facet Compression DeviceTriage Medical, Inc. · 2005 · cites it directly27descendants
- K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012 · 2 generations on26descendants
- K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017 · 2 generations on18descendants
- K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc. · 2005 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| +1 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| +1 | K052043 | 3.8MM CS Facet Compression Device | Triage Medical, Inc. | 2005 | — |
| +2 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| +2 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| +1 | K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N | Triage Medical, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | — | NuVasive™ Percutaneous Transfacet/Intrapedicular Screw Named without a submission number |
What descends from it? (48)
See all 4811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092568 | Spartan S3 Facet System | 2009 | 29 |
| K052043 | 3.8MM CS Facet Compression Device | 2005 | 27 |
| K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N | 2005 | 11 |
| K183589 | PMT Facet Screw | 2019 | 8 |
| K061041 | US Spine Facet Fixation System | 2006 | 3 |
| K101364 | Lanx Facet Screw System | 2010 | 2 |
| K101284 | Facet Screw System | 2010 | 2 |
| K101762 | Viper F2 Facet Fixation System | 2010 | 1 |
| K173198 | Facet Screw Fixation System | 2018 | 0 |
| K113011 | Spartan S3 Facet System | 2011 | 0 |
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?
- Of its descendants, K092568 (Amendia, Inc., 2009) has gone furthest, with 29 descendants of its own.
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 NuVasive™ Triad™ Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The NuVasive™ Triad™ Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 for the 3.5mm screws, and from…
Read the full statement (153 words)
The NuVasive™ Triad™ Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The NuVasive™ Triad™ Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 for the 3.5mm screws, and from L1 to S1 for the 4.5mm screws. The Triad™ Facet Screw System is indicated for treatment of any or all of the following:
(a) pseudoarthrosis and failed previous fusion;
(b) spondylolisthesis;
(c) spondylolysis;
(d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
(e) degeneration of the facets with instability; and
(g) fracture.
The NuVasive™ Triad™ Facet Screw System is intended for conventional or percutaneous surgical placement.
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/K020411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020411: Nuvasive Triad Facet Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020411
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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