510(k) Report

510(k) · Cleared

Cleared

Ion-C

K251714510(k) TraditionalCleared Jan 16, 2026227-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

SurGenTec, LLC · MRW System, Facet Screw Spinal Device

Cleared on Jan 16, 2026 as substantially equivalent to K220951 (Providence Medical Technology, Inc., 2022) and 4 other predicates after a 227-day review. Its family tree reaches back 10 generations to 2000.

Decided
Jan 16, 2026
Review
227 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K994308 (2000). 24 ancestors in all, the oldest K953076 (1997). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2019: 1 other ancestor2017: 1 other ancestor2013: 1 other ancestor2012: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2002: 2 other ancestors2005: 2 other ancestors2003: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestorK994308 · Nuvasive Townley Facet Screw · Nuvasive, Inc. · 2000K012773 · Discovery Facet Screw Fixation System · Depuyacromed · 2001K071420 · Chameleon Fixation System · Spinefrontier, Inc. · 2008 · recalledK100154 · Fixcet Spinal Facet Screw System · X-Spine Systems, Inc. · 2010K123932 · Zygafix Spinal Facet Screw System · X-Spine Systems, Inc. · 2013K132126 · Spectrum Spine Fenestrated Facet Screw System · Spectrum Spine, LLC · 2013K211855 · Ion Facet Screw System · SurGenTec, LLC · 2022K240086 · Ion 3D · SurGenTec, LLC · 2024K241416 · Ion 3D · SurGenTec, LLC · 2024K243265 · Ion 3D · SurGenTec, LLC · 20241995200020052010201520202025
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 5 other ancestors4 generations back: 6 other ancestors K243265 · Ion 3D · SurGenTec, LLC · 2024K241416 · Ion 3D · SurGenTec, LLC · 2024K240086 · Ion 3D · SurGenTec, LLC · 2024K211855 · Ion Facet Screw System · SurGenTec, LLC · 2022K132126 · Spectrum Spine Fenestrated Facet Screw System · Spectrum Spine, LLC · 2013K123932 · Zygafix Spinal Facet Screw System · X-Spine Systems, Inc. · 2013K100154 · Fixcet Spinal Facet Screw System · X-Spine Systems, Inc. · 2010K071420 · Chameleon Fixation System · Spinefrontier, Inc. · 2008 · recalledK012773 · Discovery Facet Screw Fixation System · Depuyacromed · 2001K994308 · Nuvasive Townley Facet Screw · Nuvasive, Inc. · 2000−10−50
  1. Root · 10 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
  2. 6 generations between
  3. 3 generations backK240086 Ion 3DSurGenTec, LLC · 2024
  4. 2 generations backK241416 Ion 3DSurGenTec, LLC · 2024
  5. 1 generation backK243265 Ion 3DSurGenTec, LLC · 2024
  6. This deviceK251714 Ion-CSurGenTec, LLC · 2026
Show all 10 generations
  1. Root · 10 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
  2. 9 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
  3. 8 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
  4. 7 generations backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
  5. 6 generations backK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
  6. 5 generations backK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
  7. 4 generations backK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
  8. 3 generations backK240086 Ion 3DSurGenTec, LLC · 2024
  9. 2 generations backK241416 Ion 3DSurGenTec, LLC · 2024
  10. 1 generation backK243265 Ion 3DSurGenTec, LLC · 2024
  11. This deviceK251714 Ion-CSurGenTec, LLC · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K994308Nuvasive Townley Facet ScrewNuvasive, Inc.2000—
−9K012773Discovery Facet Screw Fixation SystemDepuyacromed2001—
−8K071420Chameleon Fixation SystemSpinefrontier, Inc.20081
−7K100154Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc.2010—
−6K123932Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc.2013—
−5K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC2013—
−4K211855Ion Facet Screw SystemSurGenTec, LLC2022—
−3K240086Ion 3DSurGenTec, LLC2024—
−2K241416Ion 3DSurGenTec, LLC2024—
−1K243265Ion 3DSurGenTec, LLC2024—
0 (this device)K251714Ion-CSurGenTec, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200220
200310
200520
200810
200910
201210
201310
201710
201910
202210
FIG. 1 — Lineage of K251714, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K220951PMT Facet Fixation System (PMT FFS)
Summary page 5
…Facet Spinal Device Classification Name: Unclassified Product Code: MRW Primary Predicate Device: PMT Facet Fixation System (PMT FFS) (K220951) Additional Predicate: Ion 3D (K241416, K243265, K240086, K211855) Device Description: Ion-C is intended for bilateral…
Providence Medical Technology, Inc.2022—
*K241416Ion 3D
Summary page 5
…Unclassified Product Code: MRW Primary Predicate Device: PMT Facet Fixation System (PMT FFS) (K220951) Additional Predicate: Ion 3D (K241416, K243265, K240086, K211855) Device Description: Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or…
SurGenTec, LLC2024—
*K243265Ion 3D
Summary page 5
…Unclassified Product Code: MRW Primary Predicate Device: PMT Facet Fixation System (PMT FFS) (K220951) Additional Predicate: Ion 3D (K241416, K243265, K240086, K211855) Device Description: Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or 2-contigu…
SurGenTec, LLC2024—
*K240086Ion 3D
Summary page 5
…fied Product Code: MRW Primary Predicate Device: PMT Facet Fixation System (PMT FFS) (K220951) Additional Predicate: Ion 3D (K241416, K243265, K240086, K211855) Device Description: Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or 2-contiguous level…
SurGenTec, LLC2024—
*K211855Ion Facet Screw System
Summary page 5
…duct Code: MRW Primary Predicate Device: PMT Facet Fixation System (PMT FFS) (K220951) Additional Predicate: Ion 3D (K241416, K243265, K240086, K211855) Device Description: Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or 2-contiguous levels. Ion-C…
SurGenTec, LLC2022—

Also cleared against K220951: 3 other devices →

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 6 companies; a new generation was cleared every 2.0 years on median.
  • 1 of the 24 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K220951.

How does its category compare?

All MRW devices

MRW 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

2008: 32009: 62010: 62011: 32012: 42013: 72015: 22016: 22017: 12018: 22019: 32022: 32023: 32024: 72025: 72026 (partial year): 5
2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2008: 88 days median2009: 89 days median2010: 108 days median2011: 122 days median2012: 119 days median2013: 110 days median2019: 90 days median2022: 252 days median2023: 190 days median2024: 50 days median2025: 97 days median2026 (partial year): 169 days median
2007high 252 (2022) · low 50 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MRW

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRW

3in 2025

2007: 12009: 22010: 72011: 622012: 62013: 42014: 12015: 22016: 12017: 42018: 42021: 12023: 12024: 22025: 3
2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
200838800
200968902
2010610807
20113122362
2012411906
2013711004
20140—01
20152—02
20162—01
20171—04
20182—04
201939000
20200—00
20210—01
2022325200
2023319001
202475002
202579703
202651690—

What is it indicated for?

The Ion-C System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet joint interspace. The Ion-C is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. The Ion-C is indicated for patients requiring a revision for an anterior pseudoarthrosis at one or two contiguous levels, from C3 to C7. The Ion-C is only intended to be used in combination with an FDA-cleared anterior cervical plate and intervertebral body fusion device implanted at the same level(s). The Ion-C 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.

Also cleared against K220951

3 other devices cite the same predicate.

  • K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
  • K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024
  • K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc. · 2023

More from SurGenTec, LLC

30 FDA decisions under this applicant name. See the company

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K252995Durashield Device KitSurGenTec, LLC · 2026
  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC · 2026
  • K262121Ion-L Navigated InstrumentsSurGenTec, LLC · 2026

Recent decisions in MRW

The MRW category page

  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K261209Ion-LSurGenTec, LLC · 2026
  • K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K250679FFX Facet Fixation SystemSc Medica · 2025

https://510kreport.com/device/K251714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251714: Ion-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251714

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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