510(k) · Cleared
ClearedDepuy Motech Profile Anterior Thoracolumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 3, 1997 after a 77-day review. The FDA summary names its predicate without a number. 129 later devices descend from it.
- Decided
- Nov 3, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
129 later devices descend from it, 2 citing it directly.
- This deviceK973060 Depuy Motech Profile Anterior Thoracolumbar Plate SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 127 of its ownK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- Descendant · 2 generations on · 73 of its ownK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
- Descendant · 3 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
- Descendant · 4 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
- Descendant · 2 generations on · 50 of its ownK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006 · cites it directly127descendants
- K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010 · 2 generations on73descendants
- K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 3 generations on72descendants
- K172941CASCADIA Interbody SystemK2m · 2018 · 4 generations on52descendants
- K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006 · 2 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973060 | Depuy Motech Profile Anterior Thoracolumbar Plate System | Depuy, Inc. | 1997 | — |
| +1 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| +2 | K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX | K2m, Inc. | 2010 | — |
| +3 | K131533 | Cayman MI Plate System | K2m, Inc. | 2013 | — |
| +4 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| +2 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 15 | 0 |
| 2023 | 23 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 0 |
| 2026 | 17 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | DePuy Motech MOSS Miami Titanium Spinal System Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Spinal System - 4.0mm Named without a submission number | |
| * | — | Amset Anterior Locking Plate System Named without a submission number |
What descends from it? (129)
See all 1292 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, K062407 (Globus Medical, Inc., 2006) has gone furthest, with 127 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The DePuy Motech Profile Anterior Thoracolumbar Plate System is intended for use in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture, (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
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/K973060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973060: Depuy Motech Profile Anterior Thoracolumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973060
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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