510(k) · Cleared
ClearedIllico FS Facet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Nov 28, 2012 as substantially equivalent to K071420 (Spinefrontier, Inc., 2008) after a 44-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 28, 2012
- Review
- 44 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K994308 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 2 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 1 generation backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- This deviceK123218 Illico FS Facet Fixation SystemAlphatec Spine, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −2 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −1 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| 0 (this device) | K123218 | Illico FS Facet Fixation System | Alphatec Spine, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K101170 | FDA’s K101170 is Acute Innovations Sternal Fixation System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K071420 | Chameleon Fixation SystemSummary page 1…VII. Predicate Devices: RaptorTm Facet Fixation System - KI 10170 Chameleon Fixation System - K07 1420 VIII. Description: The ILLICO 1FS System is intended to stabilize the spine as an aid to fusion through bi… | 2008 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 10 other devices also cite its predicate K071420.
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. 2012, 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 ILLICO®)FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li to S1 inclusive. The ILLICO FS System is indicated for treatment of any or…
Read the full statement (135 words)
The ILLICO®)FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li to S1 inclusive. The ILLICO FS System is indicated for treatment of any or all of the following:
- degenerative disc disease (ODD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
- degenerative disease of the facets with instability
- trauma (i.e. fracture or dislocation)
- spondylolisthesis
- spondylolysis
- pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123218: Illico FS 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/K123218
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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