510(k) · Cleared
ClearedAcromed Anterior Cervical Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 11, 1997 after an 86-day review. The FDA summary names its predicate without a number. 72 later devices descend from it.
- Decided
- Jun 11, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
72 later devices descend from it, 1 citing it directly.
- This deviceK970955 Acromed Anterior Cervical Stabilization SystemAcromed Corp. · 1997
- Descendant · cites it directly · 71 of its ownK982443 Doc Ventral Cervical Stabilization SystemDepuy Motech Acromed · 1998
- Descendant · 2 generations on · 27 of its ownK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- Descendant · 3 generations on · 25 of its ownK053053 Pacp SystemPioneer Surgical Technology · 2005
- Descendant · 2 generations on · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
- Descendant · 4 generations on · 19 of its ownK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K982443Doc Ventral Cervical Stabilization SystemDepuy Motech Acromed · 1998 · cites it directly71descendants
- K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005 · 2 generations on27descendants
- K053053Pacp SystemPioneer Surgical Technology · 2005 · 3 generations on25descendants
- K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · 2 generations on21descendants
- K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970955 | Acromed Anterior Cervical Stabilization System | Acromed Corp. | 1997 | — |
| +1 | K982443 | Doc Ventral Cervical Stabilization System | Depuy Motech Acromed | 1998 | — |
| +2 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| +3 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| +2 | K121514 | Anodyne Anterior Cervical Plate System | Corelink, LLC | 2012 | — |
| +4 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | TOP Cervical Spine Stabilization System Named without a submission number |
What descends from it? (72)
See all 721 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982443 | Doc Ventral Cervical Stabilization System | 1998 | 71 |
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, K982443 (Depuy Motech Acromed, 1998) has gone furthest, with 71 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 Anterior Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which 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/K970955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970955: Acromed Anterior 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/K970955
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