510(k) · Cleared
ClearedModification to Townley 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 Dec 19, 2001 after a 30-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Dec 19, 2001
- Review
- 30 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK013829 Modification to Townley Transfacetpedicular Screw Fixation SystemMedtronic Sofamor Danek, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK180729 FaSet Fixation SystemHuvexel Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK222515 FaSet Fixation SystemDio Medical Corporation · 2022
- Descendant · 3 generations on · 1 of its ownK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
- Descendant · 4 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Most influential descendants
Showing 4 of 4 · See all- K180729FaSet Fixation SystemHuvexel Co., Ltd. · 2018 · cites it directly3descendants
- K222515FaSet Fixation SystemDio Medical Corporation · 2022 · 2 generations on2descendants
- K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation · 2023 · 3 generations on1descendant
- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013829 | Modification to Townley Transfacetpedicular Screw Fixation System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| +1 | K180729 | FaSet Fixation System | Huvexel Co., Ltd. | 2018 | — |
| +2 | K222515 | FaSet Fixation System | Dio Medical Corporation | 2022 | — |
| +3 | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex… | K&J Consulting Corporation | 2023 | — |
| +4 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180729 | FaSet Fixation System | 2018 | 3 |
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, K180729 (Huvexel Co., Ltd., 2018) has gone furthest, with 3 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™ 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 TOWNLEY™ 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 TOWNLEY™…
Read the full statement (244 words)
The TOWNLEY™ 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 TOWNLEY™ 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 TOWNLEY™ 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 DYNALOK® Plate is attached to the base of the spinous processes at the corresponding levels with Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.
For both 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/K013829 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013829: Modification to Townley Transfacetpedicular Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013829
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026