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 Oct 16, 2025 as substantially equivalent to K232468 (Sc Medica, 2024) and 1 other predicate after a 99-day review. Its family tree reaches back 8 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 16, 2025
- Review
- 99 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K994308 (2000). 21 ancestors in all, the oldest K953076 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 7 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 6 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 5 generations backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- 4 generations backK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
- 3 generations backK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
- 2 generations backK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- 1 generation backK232468 SC Medica FFXSc Medica · 2024
- This deviceK252153 FFX Facet Fixation SystemSc Medica · 2025
- Descendant · cites it directly · 0 of its ownK261209 Ion-LSurGenTec, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250679 FFX Facet Fixation SystemSc Medica · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −7 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −6 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −5 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| −4 | K123932 | Zygafix Spinal Facet Screw System | X-Spine Systems, Inc. | 2013 | — |
| −3 | K132126 | Spectrum Spine Fenestrated Facet Screw System | Spectrum Spine, LLC | 2013 | — |
| −2 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| −1 | K232468 | SC Medica FFX | Sc Medica | 2024 | — |
| 0 (this device) | K252153 | FFX Facet Fixation System | Sc Medica | 2025 | — |
| +1 | K261209 | Ion-L | SurGenTec, LLC | 2026 | — |
| +1 | 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 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K232468 | SC Medica FFXSummary page 5…25 Classifications: Unclassified Class: II Product Codes: MRW Primary Predicate: SC Medica FFX (K232468) Additional Predicate: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) Indications For Use: FFX is a lumbar… | 2024 |
| * | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX)Summary page 5…duct Codes: MRW Primary Predicate: SC Medica FFX (K232468) Additional Predicate: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) Indications For Use: FFX is a lumbar facet system that is placed bilaterally through a posterior surgical approach and spans t… | 2023 |
What descends from it? (2)
2 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 25 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K261209 (SurGenTec, LLC, 2026) has gone furthest, with 0 descendants of its own.
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 lumbar facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the component FFX screw through the component FFX facet cage. 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…
Read the full statement (121 words)
FFX is a lumbar facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the component FFX screw through the component FFX facet cage. 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 (DOD) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252153 · printed Nov 3, 2026
Cite this page
510(k) Report. “K252153: FFX Facet Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K252153
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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