510(k) · Cleared
ClearedMichelson Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 19, 1998 after an 87-day review. The FDA summary names its predicate without a number. 71 later devices descend from it.
- Decided
- Feb 19, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 2 citing it directly.
- This deviceK974435 Michelson Anterior Cervical Plate SystemWrightmedicaltechnologyinc · 1998
- Descendant · cites it directly · 70 of its ownK012305 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 · 2 generations on · 23 of its ownK120515 Tempus Cervical Plate SystemNeurostructures, LLC · 2012
- Descendant · 2 generations on · 22 of its ownK132012 Trinica (R) Anterior Cervical Plate System, Trinica (R) Select…Zimmer Spine, Inc. · 2013
- Descendant · 3 generations on · 22 of its ownK131374 Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K012305Modification to: Trinica Anterior Cervical Plate SystemSulzer Spine-Tech · 2001 · cites it directly70descendants
- K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · cites it directly43descendants
- K120515Tempus Cervical Plate SystemNeurostructures, LLC · 2012 · 2 generations on23descendants
- K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc. · 2013 · 2 generations on22descendants
- K131374Tempus (TM) Cervical Plate SystemNeurostructures, LLC · 2013 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974435 | Michelson Anterior Cervical Plate System | Wrightmedicaltechnologyinc | 1998 | — |
| +1 | 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 |
| +2 | K120515 | Tempus Cervical Plate System | Neurostructures, LLC | 2012 | — |
| +2 | K132012 | Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior… | Zimmer Spine, Inc. | 2013 | — |
| +3 | K131374 | Tempus (TM) Cervical Plate System | Neurostructures, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | ORION Anterior Cervical Plate Named without a submission number | |
| * | — | Synthes CSLP System Named without a submission number |
What descends from it? (71)
See all 712 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, K012305 (Sulzer Spine-Tech, 2001) has gone furthest, with 70 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 Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications: Instability caused by trauma (including fractures); Instability associated with correction of cervical lordosis, scoliosis and kyphosis deformity; Instability associated with tumors; Instability associated with degenerative disk diseases defined as back pain of discogenic origin with degeneration of the…
Read the full statement (95 words)
The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:
Instability caused by trauma (including fractures);
Instability associated with correction of cervical lordosis, scoliosis and kyphosis deformity;
Instability associated with tumors;
Instability associated with degenerative disk diseases defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
Instability from failed previous fusions.
Warning: This device is not approved for screw attachment or fixation 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/K974435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974435: Michelson Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974435
Report an extraction error
Are you the manufacturer?
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