510(k) · Cleared
Recalled · 2005Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 23, 2003 as substantially equivalent to K990005 (Spinal Concepts, Inc., 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1992. 19 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 23, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922087 (1992). 6 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 2 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 1 generation backK013979 SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2002 · Recalled
- This deviceK024326 Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK052072 The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level…Abbott Spine, Inc. · 2005
- Descendant · 2 generations on · 16 of its ownK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
- Descendant · 3 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
- Descendant · 4 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · 5 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K052072The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level PlatesAbbott Spine, Inc. · 2005 · cites it directly17descendants
- K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc. · 2015 · 2 generations on16descendants
- K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 3 generations on13descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 4 generations on10descendants
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −2 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −1 | K013979 | SC-Acufix Thinline Anterior Cervical Plate System | Spinal Concepts, Inc. | 2002 | 2 |
| 0 (this device) | K024326 | Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System | Spinal Concepts, Inc. | 2003 | — |
| +1 | K052072 | The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates | Abbott Spine, Inc. | 2005 | — |
| +2 | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical… | Zimmer Spine, Inc. | 2015 | — |
| +3 | K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2020 | — |
| +4 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +5 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSummary page 1…NAME Spinal Fixation System PROPRIETARY NAME Ant-Cer Dynamic Anterior Cervical Plate System PREDICATE DEVICE Spinal Concepts SC-AcuFix Anterior Cervical Plate System, (K990005 and K013979). This is a design moclification per established design control procedures. DEVICE DESCRIPTION The Ant-Cer Dynamic… | 1999 |
| * | K013979 | SC-Acufix Thinline Anterior Cervical Plate SystemSummary page 1…Fixation System PROPRIETARY NAME Ant-Cer Dynamic Anterior Cervical Plate System PREDICATE DEVICE Spinal Concepts SC-AcuFix Anterior Cervical Plate System, (K990005 and K013979). This is a design moclification per established design control procedures. DEVICE DESCRIPTION The Ant-Cer Dynamic Anterior Cer… | 2002 |
What descends from it? (19)
See all 192 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2005 | Not classified | Z-0292-06 | Other | Modification to labeling for surgical implant. |
| Mar 8, 2004 | Not classified | Z-1038-04 | Other | Recall of product literature that describes use of the device. |
| Mar 1, 2004 | Not classified | Z-0808-04 | Other | Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. |
| Mar 1, 2004 | Not classified | Z-0807-04 | Other | Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K052072 (Abbott Spine, Inc., 2005) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K990005.
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 Ant-Cer 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 (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
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/K024326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024326: Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024326
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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