510(k) · Cleared
ClearedModification to: Trinica Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Spine-Tech · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 22, 2001 as substantially equivalent to K974435 (Wrightmedicaltechnologyinc, 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998. 70 later devices descend from it.
- Decided
- Aug 22, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974435 (1998). 70 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK974435 Michelson Anterior Cervical Plate SystemWrightmedicaltechnologyinc · 1998
- This deviceK012305 Modification to: Trinica Anterior Cervical Plate SystemSulzer Spine-Tech · 2001
- Descendant · cites it directly · 43 of its ownK022344 Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · Recalled
- Descendant · cites it directly · 23 of its ownK120515 Tempus Cervical Plate SystemNeurostructures, LLC · 2012
- Descendant · cites it directly · 22 of its ownK132012 Trinica (R) Anterior Cervical Plate System, Trinica (R) Select…Zimmer Spine, Inc. · 2013
- Descendant · 2 generations on · 22 of its ownK131374 Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013
- Descendant · 2 generations on · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · cites it directly43descendants
- K120515Tempus Cervical Plate SystemNeurostructures, LLC · 2012 · cites it directly23descendants
- K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc. · 2013 · cites it directly22descendants
- K131374Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013 · 2 generations on22descendants
- K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974435 | Michelson Anterior Cervical Plate System | Wrightmedicaltechnologyinc | 1998 | — |
| 0 (this device) | K012305 | Modification to: Trinica Anterior Cervical Plate System | Sulzer Spine-Tech | 2001 | — |
| +1 | K022344 | Trinica Select Anterior Cervical Plate System | Centerpulse Spine-Tech, Inc. | 2002 | 1 |
| +1 | K120515 | Tempus Cervical Plate System | Neurostructures, LLC | 2012 | — |
| +1 | K132012 | Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior… | Zimmer Spine, Inc. | 2013 | — |
| +2 | K131374 | Tempus (TM) Cervical Plate System | Neurostructures, LLC | 2013 | — |
| +2 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K974435 | Michelson Anterior Cervical Plate SystemSummary page 1…ey Senior Regulatory Affairs Specialist Trinica™ Anterior Cervical Plate System Spinal Intervertebral Body Fixation Class IT, KWQ Michelson Anterior Cervical Plate K974435 concurrence date February 19, 1998 Device Description: The Trinica Anterior Cervical Plate System is a fixation device consisti… | 1998 |
What descends from it? (70)
See all 704 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?
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 Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures)…
Read the full statement (102 words)
The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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/K012305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012305: Modification to: Trinica Anterior 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/K012305
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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