510(k) · Cleared
Recalled · Class II · 2012Chameleon Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Jan 16, 2008 as substantially equivalent to K012773 (Depuyacromed, 2001) and 1 other predicate after a 239-day review. Its family tree reaches back 2 generations to 2000. 153 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2008
- Review
- 239 days
- Class
- Class U
- Product code
- MRW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K994308 (2000). 3 ancestors in all. 153 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 1 generation backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- This deviceK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008
- Descendant · cites it directly · 130 of its ownK131417 Facet FixxNexxt Spine, LLC · 2013
- Descendant · 2 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 3 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 5 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 153 · See all- K131417Facet FixxNexxt Spine, LLC · 2013 · cites it directly130descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 2 generations on106descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on100descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 5 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −1 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| 0 (this device) | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | — |
| +1 | K131417 | Facet Fixx | Nexxt Spine, LLC | 2013 | — |
| +2 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +3 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +4 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +5 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 23 | 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 |
|---|---|---|---|
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 1…tion Names System facet Screw Spinal Device Classification Unclassified, Product Code MRW Predicate Device [21 CFR 807.92(a)(3)j Depuy Discovery - K012773 Nuvasive Inc. - Townley Transfacet Screw - K994308 Description of the Device 121 CFR 807.92(a)(4)I… | 2001 |
| * | K994308 | Nuvasive Townley Facet ScrewSummary page 1…ification Unclassified, Product Code MRW Predicate Device [21 CFR 807.92(a)(3)j Depuy Discovery - K012773 Nuvasive Inc. - Townley Transfacet Screw - K994308 Description of the Device 121 CFR 807.92(a)(4)I The SpineFrontier, Inc. CHAMELEONrM Fixation System is d… | 2000 |
What descends from it? (153)
See all 15311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131417 | Facet Fixx | 2013 | 130 |
| K100154 | Fixcet Spinal Facet Screw System | 2010 | 35 |
| K123932 | Zygafix Spinal Facet Screw System | 2013 | 18 |
| K092464 | Spineology Facet Screw | 2009 | 6 |
| K102438 | Primalok Facet Fixation System | 2010 | 4 |
| K101762 | Viper F2 Facet Fixation System | 2010 | 1 |
| K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®… | 2023 | 0 |
| K123218 | Illico FS Facet Fixation System | 2012 | 0 |
| K121850 | Typhoon (TM) Facet Screw Fixation System | 2012 | 0 |
| K110170 | Raptor Facet Fixation System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2012 | Class II | Z-1871-2013 | Device Design | Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131417 (Nexxt Spine, LLC, 2013) has gone furthest, with 130 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. 2008, 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 subject device is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels including: i)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or…
Read the full statement (136 words)
The subject device is intended to stabilize the spine as an aid to fusion by
transfacet fixation.
The subject device is indicated for posterior surgical treatment of any or all of the
following at the LI to SI (inclusive) spinal levels including: i)Trauma, including
spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4)
Pseudoarthrosis or failed previous fusions which are symptomatic or which may
cause secondary instability or deformity; 5)Degenerative diseases which include:
(a) degenerative disc disease (DDD) as defined by neck and/or back pain of
discogenic origin as confirmed by patient history with degeneration of the disc as
confirmed by radiographic studies and/or (b)degenerative disease of the facets
with pain and/or instability on plain flexion and extension lateral radiographs
where there is movement of the vertebral bodies relative to each other of more
than 4mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071420: Chameleon 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/K071420
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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