510(k) · Cleared
ClearedFacet 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 Jul 15, 2010 as substantially equivalent to K012773 (Depuyacromed, 2001) and 3 other predicates after a 69-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 69 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K994308 (2000). 9 ancestors in all, the oldest K953076 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 3 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 2 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 1 generation backK092464 Spineology Facet ScrewSpineology, Inc. · 2009
- This deviceK101284 Facet Screw SystemNuvasive, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK123497 Facet Screw SystemFacet-Link, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK150223 Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −3 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −2 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −1 | K092464 | Spineology Facet Screw | Spineology, Inc. | 2009 | — |
| 0 (this device) | K101284 | Facet Screw System | Nuvasive, Inc. | 2010 | — |
| +1 | K123497 | Facet Screw System | Facet-Link, Inc. | 2013 | — |
| +2 | K150223 | Facet-Link Stabilization Platform | Facet-Link, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 1…Facet Screw System is substantially equivalent to the following devices previously cleared by FDA: DePuy AcroMed DISCOVERY Facet Screw Fixation System (K012773), NuVasive® Triad® Facet Screw System (K02041 1), Spineology® Facet Screw System (K092464), and the TransSl ® Facet Scre… | 2001 |
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 1…to the following devices previously cleared by FDA: DePuy AcroMed DISCOVERY Facet Screw Fixation System (K012773), NuVasive® Triad® Facet Screw System (K02041 1), Spineology® Facet Screw System (K092464), and the TransSl ® Facet Screw (K0735 15). D. Device Descrip… | 2002 |
| * | K092464 | Spineology Facet ScrewSummary page 1…by FDA: DePuy AcroMed DISCOVERY Facet Screw Fixation System (K012773), NuVasive® Triad® Facet Screw System (K02041 1), Spineology® Facet Screw System (K092464), and the TransSl ® Facet Screw (K0735 15). D. Device Description The NuVasive Facet Screw System cons… | 2009 |
| * | K073515 | TRANS1 Facet ScrewSummary page 1…Fixation System (K012773), NuVasive® Triad® Facet Screw System (K02041 1), Spineology® Facet Screw System (K092464), and the TransSl ® Facet Screw (K0735 15). D. Device Description The NuVasive Facet Screw System consists of fully threaded and partially threaded… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123497 | Facet Screw System | 2013 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K123497 (Facet-Link, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K012773.
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. 2010, 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?
The Nu Vasive®O Facet Screw System is intended to stabilize the spine as an aid to ifusion through immobilization of the facet joints. The NluVasive Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to SI (inclusive). The Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoartlnosis and failed previous fusion; (b) spondylolisthesis; (c) spondylolysis…
Read the full statement (116 words)
The Nu Vasive®O Facet Screw System is intended to stabilize the spine as an aid to ifusion through immobilization of the facet joints. The NluVasive Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to SI (inclusive). The Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoartlnosis 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 Facet Screw System is intended for conventional or percutaneous surgical placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101284: 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/K101284
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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