510(k) · Cleared
ClearedIon 3D
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 Dec 4, 2024 as substantially equivalent to K241416 (SurGenTec, LLC, 2024) and 1 other predicate after a 50-day review. Its family tree reaches back 9 generations to 2000. 1 later device descends from it.
- Decided
- Dec 4, 2024
- Review
- 50 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K994308 (2000). 21 ancestors in all, the oldest K953076 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 5 generations between
- 3 generations backK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- 2 generations backK240086 Ion 3DSurGenTec, LLC · 2024
- 1 generation backK241416 Ion 3DSurGenTec, LLC · 2024
- This deviceK243265 Ion 3DSurGenTec, LLC · 2024
- Descendant · cites it directly · 0 of its ownK251714 Ion-CSurGenTec, 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 backK240086 Ion 3DSurGenTec, LLC · 2024
- 1 generation backK241416 Ion 3DSurGenTec, LLC · 2024
- This deviceK243265 Ion 3DSurGenTec, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K251714Ion-CSurGenTec, LLC · 2026 · cites it directly0descendants
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 | K240086 | Ion 3D | SurGenTec, LLC | 2024 | — |
| −1 | K241416 | Ion 3D | SurGenTec, LLC | 2024 | — |
| 0 (this device) | K243265 | Ion 3D | SurGenTec, LLC | 2024 | — |
| +1 | K251714 | Ion-C | 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 |
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? (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 |
|---|---|---|---|
| * | K241416 | Ion 3DSummary page 5…Unclassified 21 CFR 880.5860 Product Code: MRW, FMF, HTR Primary Predicate: Ion 3D Facet Screw (K241416) Additional Predicate: Ion Facet Screw System (K211855) Device Description: The Ion 3D contains various sized facet sc… | 2024 |
| * | K211855 | Ion Facet Screw SystemSummary page 5…80.5860 Product Code: MRW, FMF, HTR Primary Predicate: Ion 3D Facet Screw (K241416) Additional Predicate: Ion Facet Screw System (K211855) Device Description: The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization o… | 2022 |
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 |
|---|---|---|---|
| K251714 | Ion-C | 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 24 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K251714 (SurGenTec, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K241416.
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. 2024, 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 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis Spondylolysis Pseudoarthrosis or failed…
Read the full statement (124 words)
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw 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 Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
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/K243265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243265: Ion 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243265
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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