510(k) · Cleared
ClearedSpineology Facet Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Nov 9, 2009 as substantially equivalent to K071420 (Spinefrontier, Inc., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.
- Decided
- Nov 9, 2009
- Review
- 90 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K994308 (2000). 7 ancestors in all, the oldest K953076 (1997). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 2 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 1 generation backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- This deviceK092464 Spineology Facet ScrewSpineology, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK101284 Facet Screw SystemNuvasive, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK123497 Facet Screw SystemFacet-Link, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK101762 Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK192281 AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System…Medos International SARL · 2019
- Descendant · 3 generations on · 0 of its ownK150223 Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101284Facet Screw SystemNuvasive, Inc. · 2010 · cites it directly2descendants
- K123497Facet Screw SystemFacet-Link, Inc. · 2013 · 2 generations on1descendant
- K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010 · cites it directly1descendant
- K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL · 2019 · 2 generations on0descendants
- K150223Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −2 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −1 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| 0 (this device) | K092464 | Spineology Facet Screw | Spineology, Inc. | 2009 | — |
| +1 | K101284 | Facet Screw System | Nuvasive, Inc. | 2010 | — |
| +2 | K123497 | Facet Screw System | Facet-Link, Inc. | 2013 | — |
| +1 | K101762 | Viper F2 Facet Fixation System | Depuy Spine, Inc. | 2010 | — |
| +2 | K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior… | Medos International SARL | 2019 | — |
| +3 | 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 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K071420 | Chameleon Fixation SystemSummary page 1…fication and Unclassified, Product Code MRW Code: T ~~~~~~~~~~TM Predicate Device(s): K071420 ChameleonT mFixation System (SpineFrontier, Inc.) K(073515 TranS 1 Facet Screws (TranS l,®0 Inc.)… | 2008 |
| * | K073515 | TRANS1 Facet ScrewSummary page 1…T ~~~~~~~~~~TM Predicate Device(s): K071420 ChameleonT mFixation System (SpineFrontier, Inc.) K(073515 TranS 1 Facet Screws (TranS l,®0 Inc.) The Spineology Facet Screw System is designed to provide bilat… | 2008 |
What descends from it? (6)
3 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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K101284 (Nuvasive, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 10 other devices also cite its predicate K071420.
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. 2009, 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 Spineology Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The device is indicated for posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic 'Studies and/or degenerative disease of the facets with instability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092464: Spineology Facet Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092464
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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