510(k) · Cleared
ClearedUS Spine Facet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Spine · MRW System, Facet Screw Spinal Device
Cleared on Jun 19, 2006 as substantially equivalent to K012773 (Depuyacromed, 2001) and 3 other predicates after a 66-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 19, 2006
- Review
- 66 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K994308 (2000). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 1 generation backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- This deviceK061041 US Spine Facet Fixation SystemUs Spine · 2006
- 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 · cites it directly · 0 of its ownK112097 Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- 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
- K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −1 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| 0 (this device) | K061041 | US Spine Facet Fixation System | Us Spine | 2006 | — |
| +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 | — |
| +1 | K112097 | Gibralt Spine Systems Facet Screw 04.0,04.5 | Exactech, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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? (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 System | 2001 |
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 1…et Screw Spinal Device System Classification: Class II Predicate Devices: DISCOVERY Facet Screw (KO 12773) Triad Facet Screw System (K02041 1) Oasys Bane Screw (K03 1657) Towaley Transfacetllntrapedicular Screw (K994308) Dev… | 2002 |
| * | K031657 | Stryker Spine Oasys Bone ScrewSummary page 1…Class II Predicate Devices: DISCOVERY Facet Screw (KO 12773) Triad Facet Screw System (K02041 1) Oasys Bane Screw (K03 1657) Towaley Transfacetllntrapedicular Screw (K994308) Device Description: The US Spine Facet Fixation Sys… | 2003 |
| * | K994308 | Nuvasive Townley Facet ScrewSummary page 1…Triad Facet Screw System (K02041 1) Oasys Bane Screw (K03 1657) Towaley Transfacetllntrapedicular Screw (K994308) Device Description: The US Spine Facet Fixation System consists of two implantable componenjs, the sc… | 2000 |
What descends from it? (3)
2 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 6 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K101762 (Depuy Spine, Inc., 2010) 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.
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 Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to SI (inclusive) spinal levels: 1)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined…
Read the full statement (114 words)
The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to SI (inclusive) spinal levels: 1)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061041: US Spine Facet Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061041
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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