510(k) · Cleared
ClearedDoc Ventral Cervical Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Motech Acromed · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 29, 1998 as substantially equivalent to K970955 (Acromed Corp., 1997) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1997. 71 later devices descend from it.
- Decided
- Jul 29, 1998
- Review
- 15 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970462 (1997). 2 ancestors in all. 71 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK970462 Acromed Anterior Cervical Stabilization SystemAcromed Corp. · 1997
- This deviceK982443 Doc Ventral Cervical Stabilization SystemDepuy Motech Acromed · 1998
- Descendant · cites it directly · 27 of its ownK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- Descendant · 2 generations on · 25 of its ownK053053 Pacp SystemPioneer Surgical Technology · 2005
- Descendant · cites it directly · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
- Descendant · 3 generations on · 19 of its ownK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005 · cites it directly27descendants
- K053053Pacp SystemPioneer Surgical Technology · 2005 · 2 generations on25descendants
- K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · cites it directly21descendants
- K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008 · 3 generations on19descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970462 | Acromed Anterior Cervical Stabilization System | Acromed Corp. | 1997 | — |
| 0 (this device) | K982443 | Doc Ventral Cervical Stabilization System | Depuy Motech Acromed | 1998 | — |
| +1 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| +2 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| +1 | K121514 | Anodyne Anterior Cervical Plate System | Corelink, LLC | 2012 | — |
| +3 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| +2 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K970955 | Acromed Anterior Cervical Stabilization SystemSummary page 4…e- operation for failed fusion, or instability following surgery for the above indications. SUBSTANTIAL EQUIVALENCY The AcroMed Anterior Cervical Stabilization System; K970955 and K970462 L SERVICEg ¥ 23 / C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Admi… | 1997 |
| * | K970462 | Acromed Anterior Cervical Stabilization SystemSummary page 4…for failed fusion, or instability following surgery for the above indications. SUBSTANTIAL EQUIVALENCY The AcroMed Anterior Cervical Stabilization System; K970955 and K970462 L SERVICEg ¥ 23 / C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9… | 1997 |
What descends from it? (71)
See all 717 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043066 | Pioneer Anterior Cervical Plate System | 2005 | 27 |
| K121514 | Anodyne Anterior Cervical Plate System | 2012 | 21 |
| K051815 | Modification to Vertebron SCP Cervical Plate System | 2005 | 10 |
| K190227 | Boomerang™ Anterior Cervical Plate System | 2019 | 4 |
| K112809 | Blue Mountain Cervical Plate | 2012 | 2 |
| K071990 | Valeo Cervical Plate System | 2007 | 1 |
| K073500 | Active Anterior Cervical Plate System | 2008 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K043066 (Pioneer Surgical Technology, 2005) has gone furthest, with 27 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 AcroMed DOC™ Ventral Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma (including fracture), post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). re-operation for failed fusion, or instability following surgery for the above indications.
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/K982443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982443: Doc Ventral Cervical Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982443
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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