510(k) · Cleared
ClearedTownley Facet/Pedicular Screw Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · MRW System, Facet Screw Spinal Device
Cleared on Feb 28, 1997 after a 609-day review. The FDA summary names no predicate by number. 1 of the 358 devices in its family, counting itself, has a Class I recall. 357 later devices descend from it.
- Decided
- Feb 28, 1997
- Review
- 609 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
357 later devices descend from it, 5 citing it directly. 1 of the 358 devices in this family, counting this one, has a Class I recall.
- This deviceK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- Descendant · cites it directly · 222 of its ownK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- Descendant · 2 generations on · 192 of its ownK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- Descendant · 2 generations on · 165 of its ownK143471 VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 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
Showing 5 of 357 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 357 · See all- K062254Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008 · cites it directly222descendants
- K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · 2 generations on192descendants
- K143471VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on165descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| +1 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +2 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| +2 | K143471 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K131417 | Facet Fixx | Nexxt Spine, LLC | 2013 | — |
| +2 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 19 | 0 |
| 2016 | 18 | 0 |
| 2017 | 18 | 0 |
| 2018 | 16 | 0 |
| 2019 | 20 | 0 |
| 2020 | 25 | 0 |
| 2021 | 17 | 1 |
| 2022 | 33 | 0 |
| 2023 | 42 | 0 |
| 2024 | 42 | 0 |
| 2025 | 46 | 0 |
| 2026 | 41 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (357)
See all 3575 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K062254 (Medtronic Sofamor Danek, Inc., 2008) has gone furthest, with 222 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 TRANSFACETPEDICULAR Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TRANSFACETPEDICULAR Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle. In the second fixation method, the TRANSFACETPEDICULAR Screws are…
Read the full statement (238 words)
The TRANSFACETPEDICULAR Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TRANSFACETPEDICULAR Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle. In the second fixation method, the TRANSFACETPEDICULAR Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNA-LOK® Plate is attached to the base of the spinous processes at the corresponding levels with TRANSFACETPEDICULAR Screws. The second fixation method shouid be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.
This system is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
1. Trauma, including spinal fractures and/or dislocations.
2. Spondylolisthesis.
3. Spondylolysis.
4. Pseudarthrosis 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 instability.
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/K953076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953076: Townley Facet/Pedicular Screw Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953076
Report an extraction error
Are you the manufacturer?
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