510(k) · Cleared
ClearedTownley Transfacetpedicular Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Jan 17, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 166 later devices descend from it.
- Decided
- Jan 17, 2001
- Review
- 28 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
166 later devices descend from it, 5 citing it directly.
- This deviceK003928 Townley Transfacetpedicular Screw Fixation SystemMedtronic Sofamor Danek, Inc. · 2001
- Descendant · cites it directly · 158 of its ownK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- Descendant · 2 generations on · 153 of its ownK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 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
Showing 5 of 166 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 166 · See all- K012773Discovery Facet Screw Fixation SystemDepuyacromed · 2001 · cites it directly158descendants
- K071420Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · 2 generations on153descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003928 | Townley Transfacetpedicular Screw Fixation System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| +1 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| +2 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (166)
See all 1665 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?
- Of its descendants, K012773 (Depuyacromed, 2001) has gone furthest, with 158 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.
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 | — |
https://510kreport.com/device/K003928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003928: Townley Transfacetpedicular Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003928
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026