510(k) · Cleared
ClearedFFX Facet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sc Medica · MRW System, Facet Screw Spinal Device
Cleared on Dec 4, 2025 as substantially equivalent to K241035 (Providence Medical Technology, Inc., 2024) and 1 other predicate after a 273-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Dec 4, 2025
- Review
- 273 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K994308 (2000). 25 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 deviceK250679 FFX Facet Fixation SystemSc Medica · 2025
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 deviceK250679 FFX Facet Fixation SystemSc Medica · 2025
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) | K250679 | FFX Facet Fixation System | Sc Medica | 2025 | — |
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 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K241035 | PMT Posterior Cervical Stabilization System (PCSS)Summary page 5…MRW Primary Predicate: Providence Medical Technology, Inc., PMT Posterior Cervical Stabilization System (PCSS) (K241035) Additional Predicate: SC Medica, FFX Facet Fixation System (K252153) Indications For Use: FFX is a facet system that… | 2024 |
| * | K252153 | FFX Facet Fixation System Cleared while this submission was under review Summary page 5…, Inc., PMT Posterior Cervical Stabilization System (PCSS) (K241035) Additional Predicate: SC Medica, FFX Facet Fixation System (K252153) Indications For Use: FFX is a facet system that is placed bilaterally through a posterior surgical approach and spans the facet… | 2025 |
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 25 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 25 ancestors has a recall of any class.
- 2 other devices also cite its predicate K241035.
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. 2025, 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?
FFX is a facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the components FFX screw through the component FFX facet cage. Please refer to the Instructions for Use for the device size listings intended for cervical and lumbar use. FFX is intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one…
Read the full statement (241 words)
FFX is a facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the components FFX screw through the component FFX facet cage. Please refer to the Instructions for Use for the device size listings intended for cervical and lumbar use.
FFX is intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. FFX is indicated for the treatment of patients with lumbar 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 from L3 to S1 in skeletally mature patients who have failed conservative care.
FFX is intended to provide temporary fixation and stabilization to the cervical spine as an adjunct to posterior cervical fusion (PCF) through bilateral immobilization of the facet joints and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF), at the same level(s), in up to 3 consecutive levels of the cervical spine (C3-C7). FFX is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. FFX is to be used with autogenous bone 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/K250679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250679: FFX Facet Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250679
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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