510(k) · Cleared
ClearedNuvasive Townley Facet Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Apr 18, 2000 after a 119-day review. The FDA summary names its predicate without a number. 159 later devices descend from it.
- Decided
- Apr 18, 2000
- Review
- 119 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
159 later devices descend from it, 3 citing it directly.
- This deviceK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- Descendant · cites it directly · 158 of its ownK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- Descendant · cites it directly · 153 of its ownK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 130 of its ownK131417 Facet FixxNexxt Spine, LLC · 2013
- Descendant · 3 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 4 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
Showing 5 of 159 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 159 · See all- K012773Discovery Facet Screw Fixation SystemDepuyacromed · 2001 · cites it directly158descendants
- K071420Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · cites it directly153descendants
- K131417Facet FixxNexxt Spine, LLC · 2013 · 2 generations on130descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 3 generations on106descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 4 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| +1 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| +1 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| +2 | K131417 | Facet Fixx | Nexxt Spine, LLC | 2013 | — |
| +3 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +4 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 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 | 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? (1)
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 |
|---|---|---|---|
| * | — | Townley Bone Graft Screw (also known as the Townley Compression Screw) Named without a submission number |
What descends from it? (159)
See all 1593 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 | — |
What is it indicated for?
The Townley Tranfacet/Intrapedicular Screw 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 Townley Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, and from C2 to S1, for treatment of any or all of the following…
Read the full statement (115 words)
The Townley Tranfacet/Intrapedicular Screw 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 Townley Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, and from C2 to S1, for treatment of any or all of the following:
(a) pseudoarthrosis and failed previous fusion,
(b) spondylolisthesis,
(c) spondylolysis;
(d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,
(e) degeneration of the facets with instability; and
(f) fracture
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994308: Nuvasive Townley Facet Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994308
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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