510(k) · Cleared
ClearedIon-L
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 Jun 11, 2026 as substantially equivalent to K230840 (Providence Medical Technology, Inc., 2023) and 1 other predicate after a 59-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Jun 11, 2026
- Review
- 59 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K994308 (2000). 22 ancestors in all, the oldest K953076 (1997). No later device cites it as a predicate yet.
- Root · 9 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 5 generations between
- 3 generations backK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- 2 generations backK232468 SC Medica FFXSc Medica · 2024
- 1 generation backK252153 FFX Facet Fixation SystemSc Medica · 2025
- This deviceK261209 Ion-LSurGenTec, LLC · 2026
Show all 9 generations
- Root · 9 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 8 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 7 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 6 generations backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- 5 generations backK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
- 4 generations backK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
- 3 generations backK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- 2 generations backK232468 SC Medica FFXSc Medica · 2024
- 1 generation backK252153 FFX Facet Fixation SystemSc Medica · 2025
- This deviceK261209 Ion-LSurGenTec, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −8 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −7 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −6 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| −5 | K123932 | Zygafix Spinal Facet Screw System | X-Spine Systems, Inc. | 2013 | — |
| −4 | K132126 | Spectrum Spine Fenestrated Facet Screw System | Spectrum Spine, LLC | 2013 | — |
| −3 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| −2 | K232468 | SC Medica FFX | Sc Medica | 2024 | — |
| −1 | K252153 | FFX Facet Fixation System | Sc Medica | 2025 | — |
| 0 (this device) | K261209 | Ion-L | SurGenTec, LLC | 2026 | — |
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 |
| 2023 | 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 |
|---|---|---|---|
| * | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX)Summary page 5…n Name: Unclassified Product Code: MRW Primary Predicate: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) Additional Predicate: FFX Facet Fixation System (K252153) Reference Device: Ion-C (K251714) Reference Devic… | 2023 |
| * | K252153 | FFX Facet Fixation SystemSummary page 5…imary Predicate: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) Additional Predicate: FFX Facet Fixation System (K252153) Reference Device: Ion-C (K251714) Reference Device: Ion 3D (K241416, K243265, K240086, K211855) Device… | 2025 |
| † | K251714 | Ion-C | 2026 |
| † | K241416 | Ion 3D | 2024 |
| † | K243265 | Ion 3D | 2024 |
| † | K240086 | Ion 3D | 2024 |
| † | K211855 | Ion Facet Screw System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 22 ancestors has a recall of any class.
- 5 other devices also cite its predicate K230840.
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. 2026, 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-L System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet interspace. Ion-L is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care.
Ion-L is intended to provide temporary stabilization as an adjunct to a 1-level interbody lumbar fusion. The Ion-L is intended to be used with an FDA-cleared intervertebral body fusion device implanted at the same level. The Ion-L is intended for use with autogenous and/or allogenic bone graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261209: Ion-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261209
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026