510(k) · Cleared
ClearedWolff's Law Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Simplicity, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 24, 2024 as substantially equivalent to K083020 (Stryker Corp., 2009) and 2 other predicates after an 84-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- May 24, 2024
- Review
- 84 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K922087 (1992). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 5 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 4 generations backK013979 SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2002 · Recalled
- 3 generations backK024326 Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2003 · Recalled
- 2 generations backK052072 The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level…Abbott Spine, Inc. · 2005
- 1 generation backK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
- This deviceK240592 Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −5 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −4 | K013979 | SC-Acufix Thinline Anterior Cervical Plate System | Spinal Concepts, Inc. | 2002 | 2 |
| −3 | K024326 | Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System | Spinal Concepts, Inc. | 2003 | 4 |
| −2 | K052072 | The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates | Abbott Spine, Inc. | 2005 | — |
| −1 | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical… | Zimmer Spine, Inc. | 2015 | — |
| 0 (this device) | K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K083020 | Stryker Spine Reflex Translational Anterior Cervical Plating SystemSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K083020 DynaTran Anterior Cervical Plating (ACP) System KWQ K143626… | 2009 |
| * | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Summary page 4…Product Code K083020 DynaTran Anterior Cervical Plating (ACP) System KWQ K143626 SC-AcuFix® Ant-Cer Dynamic Cervical Plating System KWQ K051665… | 2015 |
| * | K051665 | Synthes Vectra-T SystemSummary page 4…ystem KWQ K143626 SC-AcuFix® Ant-Cer Dynamic Cervical Plating System KWQ K051665 Synthes Vectra-T System KWQ Device Desc… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 12 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K083020.
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. 2024, 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 Wolff’s Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
• Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
• Spondylolisthesis;
• Spinal Stenosis;
• Trauma (including fractures);
• Tumor;
• Deformity (i.e., scoliosis, kyphosis, and/or lordosis);
• Pseudoarthrosis; and
• Failed previous fusions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240592: Wolff's Law 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/K240592
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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