510(k) · Cleared
ClearedFacet Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · MRW System, Facet Screw Spinal Device
Cleared on Aug 9, 2013 as substantially equivalent to K073515 (Trans1 Incorporated, 2008) after a 134-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Aug 9, 2013
- Review
- 134 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 2 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 1 generation backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- This deviceK130863 Facet Screw SystemSpinal USA · 2013
- Descendant · cites it directly · 0 of its ownK253432 DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −2 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −1 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| 0 (this device) | K130863 | Facet Screw System | Spinal USA | 2013 | — |
| +1 | K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K073515 | TRANS1 Facet ScrewSummary page 2…able in different diameters and lengths to accommodate patient anatomy and are substantially equivalent to the predicate devices. PREDICATE DEVICE: TranSi Facet Screw, K073515 5.2… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253432 | DiversiVy™ Facet Screw System | 2026 | 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253432 (Vy Spine, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K073515.
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. 2013, 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 Spinal USA 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 with or without bone graft, at single or multiple levels, of any or all of the following spinal levels Li to S1 (inclusive): Spondylolisthesis, Spondylolysis, 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/K130863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130863: 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/K130863
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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