510(k) · Cleared
ClearedFacet Fixx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexxt Spine, LLC · MRW System, Facet Screw Spinal Device
Cleared on Jul 12, 2013 as substantially equivalent to K012773 (Depuyacromed, 2001) and 4 other predicates after a 57-day review. Its family tree reaches back 3 generations to 2000. 130 later devices descend from it.
- Decided
- Jul 12, 2013
- Review
- 57 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K994308 (2000). 6 ancestors in all, the oldest K953076 (1997). 130 later devices descend from it, 3 citing it directly.
- 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 deviceK131417 Facet FixxNexxt Spine, LLC · 2013
- Descendant · cites it directly · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 2 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 5 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · cites it directly106descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 2 generations on100descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 5 generations on69descendants
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) | K131417 | Facet Fixx | Nexxt Spine, LLC | 2013 | — |
| +1 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +2 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +3 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +4 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +5 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 0 |
| 2022 | 15 | 0 |
| 2023 | 18 | 0 |
| 2024 | 23 | 0 |
| 2025 | 28 | 0 |
| 2026 | 22 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 1…FixxrM System is manufactured from titanium alloy (Ti-6A1- 4V ELI) as described by ASTIM F1 36. Predicate Devices: Discoveryo Facet Screw (1(012773), CHAMELEON TM (K(071420) and the TOWNLEY (K953076/K003928/K021705) Performance D… | 2001 |
| * | K071420 | Chameleon Fixation SystemSummary page 1…(Ti-6A1- 4V ELI) as described by ASTIM F1 36. Predicate Devices: Discoveryo Facet Screw (1(012773), CHAMELEON TM (K(071420) and the TOWNLEY (K953076/K003928/K021705) Performance Data: Static and dynamic cantilever bending… | 2008 |
| * | K953076 | Townley Facet/Pedicular Screw Plating SystemSummary page 1…ribed by ASTIM F1 36. Predicate Devices: Discoveryo Facet Screw (1(012773), CHAMELEON TM (K(071420) and the TOWNLEY (K953076/K003928/K021705) Performance Data: Static and dynamic cantilever bending (ASTM F2193) and axial pul… | 1997 |
| * | K003928 | Townley Transfacetpedicular Screw Fixation SystemSummary page 1…ASTIM F1 36. Predicate Devices: Discoveryo Facet Screw (1(012773), CHAMELEON TM (K(071420) and the TOWNLEY (K953076/K003928/K021705) Performance Data: Static and dynamic cantilever bending (ASTM F2193) and axial pullout tes… | 2001 |
| * | K021705 | Modification to Townley Transfacepedicular Screw Fixation SystemSummary page 1…1 36. Predicate Devices: Discoveryo Facet Screw (1(012773), CHAMELEON TM (K(071420) and the TOWNLEY (K953076/K003928/K021705) Performance Data: Static and dynamic cantilever bending (ASTM F2193) and axial pullout tests (ASTM… | 2002 |
What descends from it? (130)
See all 1303 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 13 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K141376 (Nexxt Spine, LLC, 2014) has gone furthest, with 106 descendants of its own.
- 13 other devices also cite its predicate K012773.
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. 2013, 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 Facet Fixx System is intended to stabilize the spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint…
Read the full statement (168 words)
The Facet Fixx System is intended to stabilize the spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to Si inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
* Degenerative disc disease (DOD) 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/K131417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131417: Facet Fixx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131417
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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