510(k) · Cleared
ClearedModification of Townley Pedicle Screw Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 12, 1998 after a 22-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Nov 12, 1998
- Review
- 22 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK983706 Modification of Townley Pedicle Screw Plating SystemSofamor Danek USA,Inc. · 1998
- Descendant · cites it directly · 13 of its ownK031354 Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2003
- Descendant · 2 generations on · 11 of its ownK082353 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · 2 generations on · 11 of its ownK083230 Mercury Spinal SystemSpinal Elements, Inc. · 2008
- Descendant · 3 generations on · 10 of its ownK091587 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · 3 generations on · 9 of its ownK141372 Mercury Spinal SystemSpinal Elements, Inc. · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K031354Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2003 · cites it directly13descendants
- K082353Mercury Spinal SystemSpinal Elements, Inc. · 2009 · 2 generations on11descendants
- K083230Mercury Spinal SystemSpinal Elements, Inc. · 2008 · 2 generations on11descendants
- K091587Mercury Spinal SystemSpinal Elements, Inc. · 2009 · 3 generations on10descendants
- K141372Mercury Spinal SystemSpinal Elements, Inc. · 2014 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983706 | Modification of Townley Pedicle Screw Plating System | Sofamor Danek USA,Inc. | 1998 | — |
| +1 | K031354 | Ebi OMEGA21 Spinal Fixation System | Ebi, L.P. | 2003 | — |
| +2 | K082353 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +2 | K083230 | Mercury Spinal System | Spinal Elements, Inc. | 2008 | — |
| +3 | K091587 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +3 | K141372 | Mercury Spinal System | Spinal Elements, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 Pedicle Screw Plating System Named without a submission number |
What descends from it? (19)
See all 192 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, K031354 (Ebi, L.P., 2003) has gone furthest, with 13 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® Plate is positioned over the pedicles. TOWNLEY Pedicle screws are then inserted through the plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure. This system is indicated for the treatment of any or all of the following at the C2 to S1…
Read the full statement (169 words)
The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® Plate is positioned over the pedicles. TOWNLEY Pedicle screws are then inserted through the plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure.
This system is indicated for the treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: (a) Trauma, including spinal fractures and/or dislocations, (b) Spondylolisthesis, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (e) Degenerative disc disease and/or degenerative diseases which include: (1) 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 (2) degenerative disease of the facets with instability.
For all these indications, bone graft must be used and the system is limited to screw fixation from C2 to S1.
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/K983706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983706: Modification of Townley Pedicle 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/K983706
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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