510(k) · Cleared
ClearedIon Facet Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SurGenTec, LLC · MRW System, Facet Screw Spinal Device
Cleared on Feb 25, 2022 as substantially equivalent to K163374 (Providence Medical Technology, Inc., 2017) and 1 other predicate after a 254-day review. Its family tree reaches back 6 generations to 2000. 10 later devices descend from it.
- Decided
- Feb 25, 2022
- Review
- 254 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K994308 (2000). 18 ancestors in all, the oldest K953076 (1997). 10 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 5 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 4 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 3 generations backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- 2 generations backK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
- 1 generation backK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
- This deviceK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- Descendant · cites it directly · 3 of its ownK232468 SC Medica FFXSc Medica · 2024
- Descendant · cites it directly · 3 of its ownK240086 Ion 3DSurGenTec, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK252153 FFX Facet Fixation SystemSc Medica · 2025
- Descendant · 2 generations on · 2 of its ownK241416 Ion 3DSurGenTec, LLC · 2024
- Descendant · cites it directly · 1 of its ownK243265 Ion 3DSurGenTec, LLC · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K232468SC Medica FFXSc Medica · 2024 · cites it directly3descendants
- K240086Ion 3DSurGenTec, LLC · 2024 · cites it directly3descendants
- K252153FFX Facet Fixation SystemSc Medica · 2025 · 2 generations on2descendants
- K241416Ion 3DSurGenTec, LLC · 2024 · 2 generations on2descendants
- K243265Ion 3DSurGenTec, LLC · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −5 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −4 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −3 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| −2 | K123932 | Zygafix Spinal Facet Screw System | X-Spine Systems, Inc. | 2013 | — |
| −1 | K132126 | Spectrum Spine Fenestrated Facet Screw System | Spectrum Spine, LLC | 2013 | — |
| 0 (this device) | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| +1 | K232468 | SC Medica FFX | Sc Medica | 2024 | — |
| +1 | K240086 | Ion 3D | SurGenTec, LLC | 2024 | — |
| +2 | K252153 | FFX Facet Fixation System | Sc Medica | 2025 | — |
| +2 | K241416 | Ion 3D | SurGenTec, LLC | 2024 | — |
| +1 | K243265 | Ion 3D | SurGenTec, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K163374 | ALLY™ Facet ScrewsSummary page 4…Primary Predicate: ALLY™ Facet Screws PROVIDENCE MEDICAL TECHNOLOGY, INC. 510(k) number: K163374 Additional Predicate: SS Fenestrated Facet Screw System SPECTRUM SPINE, LLC… | 2017 |
| * | K132126 | Spectrum Spine Fenestrated Facet Screw SystemSummary page 4…Additional Predicate: SS Fenestrated Facet Screw System SPECTRUM SPINE, LLC 510(k) number: K132126 5.4 Device Description The Ion Facet Screw System contains various sized facet screws for bilateral stab… | 2013 |
What descends from it? (10)
6 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 22 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K232468 (Sc Medica, 2024) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K163374.
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. 2022, 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 Ion Facet Screw System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
• 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 the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The system is intended for use with bone graft material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211855: Ion Facet Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211855
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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