510(k) · Cleared
ClearedTempus Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 23, 2012 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 1 other predicate after a 92-day review. Its family tree reaches back 2 generations to 1998. 23 later devices descend from it.
- Decided
- May 23, 2012
- Review
- 92 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974435 (1998). 3 ancestors in all. 23 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK974435 Michelson Anterior Cervical Plate SystemWrightmedicaltechnologyinc · 1998
- 1 generation backK012305 Modification to: Trinica Anterior Cervical Plate SystemSulzer Spine-Tech · 2001
- This deviceK120515 Tempus Cervical Plate SystemNeurostructures, LLC · 2012
- Descendant · cites it directly · 22 of its ownK131374 Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013
- Descendant · cites it directly · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- Descendant · 2 generations on · 15 of its ownK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · 3 generations on · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · 3 generations on · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K131374Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013 · cites it directly22descendants
- K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · cites it directly19descendants
- K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on15descendants
- K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · 3 generations on14descendants
- K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974435 | Michelson Anterior Cervical Plate System | Wrightmedicaltechnologyinc | 1998 | — |
| −1 | K012305 | Modification to: Trinica Anterior Cervical Plate System | Sulzer Spine-Tech | 2001 | — |
| 0 (this device) | K120515 | Tempus Cervical Plate System | Neurostructures, LLC | 2012 | — |
| +1 | K131374 | Tempus (TM) Cervical Plate System | Neurostructures, LLC | 2013 | — |
| +1 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| +2 | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | 2018 | — |
| +3 | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
| +3 | K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 1…C ls sfiatonPanel:-- --- ,F~rthoPedic and Rehabilitation Devices Panel Predicate Devices: Synthes CSLP Cervical Plate (K030866) Centerpulse Spine-Tech Trinica Select m Anterior Cervical Plate… | 2003 |
| * | K012305 | Modification to: Trinica Anterior Cervical Plate SystemSummary page 1…030866) Centerpulse Spine-Tech Trinica Select m Anterior Cervical Plate _____ ISystem (K012305) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Tempus M Cervical Plate System consists of screws and plates.… | 2001 |
What descends from it? (23)
See all 234 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131374 (Neurostructures, LLC, 2013) has gone furthest, with 22 descendants of its own.
- 41 other devices also cite its predicate K030866.
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. 2012, this device’s year, is highlighted.
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 Tempus' TM Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DOD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudloarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120515: Tempus Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120515
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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