510(k) · Cleared
Recalled · 2005Spinal Concepts, Inc. (Sci) 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 Feb 12, 1999 as substantially equivalent to K973854 (Sofamor Danek USA,Inc., 1998) and 3 other predicates after a 39-day review. Its family tree reaches back 1 generation to 1992. 313 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 1999
- Review
- 39 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K922087 (1992). 4 ancestors in all. 313 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- This deviceK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999
- Descendant · cites it directly · 289 of its ownK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- Descendant · 2 generations on · 145 of its ownK050813 Abc 2 ScrewAesculap, Inc. · 2005
- Descendant · 3 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
- Descendant · 4 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 2 generations on · 101 of its ownK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
Showing 5 of 313 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 313 · See all- K000486Abc Cervical Plating SystemAesculap, Inc. · 2000 · cites it directly289descendants
- K050813Abc 2 ScrewAesculap, Inc. · 2005 · 2 generations on145descendants
- K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 3 generations on132descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 4 generations on106descendants
- K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012 · 2 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| 0 (this device) | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | — |
| +1 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| +2 | K050813 | Abc 2 Screw | Aesculap, Inc. | 2005 | — |
| +3 | K133475 | Struxxure Anterior Cervical Plate and Screws | Nexxt Spine, LLC | 2013 | — |
| +4 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +2 | K122910 | Archon Anterior Cervical Plate Syste, | Nu Vasive, Incorporated | 2012 | — |
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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 16 | 0 |
| 2020 | 25 | 0 |
| 2021 | 19 | 0 |
| 2022 | 27 | 0 |
| 2023 | 39 | 0 |
| 2024 | 37 | 0 |
| 2025 | 39 | 0 |
| 2026 | 38 | 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? (4)
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 |
|---|---|---|---|
| * | K973854 | Orion Anterior Cervical Plate SystemSummary page 1…rvical Plate System is claimed to be substantially equivalent in material, design, function, and intended use to the SOFAMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and to the SYNTHES Cervical Locking Plate System (K945700 and K926453). Device Description The Spinal Concepts, In… | 1998 |
| * | K922087 | Anterior Cervical Plate SystemSummary page 1…System is claimed to be substantially equivalent in material, design, function, and intended use to the SOFAMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and to the SYNTHES Cervical Locking Plate System (K945700 and K926453). Device Description The Spinal Concepts, Inc. (SCI) Ant… | 1992 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 1…al, design, function, and intended use to the SOFAMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and to the SYNTHES Cervical Locking Plate System (K945700 and K926453). Device Description The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System components are temporary implan… | 1995 |
| * | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSummary page 1…function, and intended use to the SOFAMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and to the SYNTHES Cervical Locking Plate System (K945700 and K926453). Device Description The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System components are temporary implants that are… | 1993 |
What descends from it? (313)
See all 3135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K000486 | Abc Cervical Plating System | 2000 | 289 |
| K013979 | SC-Acufix Thinline Anterior Cervical Plate System | 2002 | 21 |
| K024326 | Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System | 2003 | 19 |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating… | 2015 | 16 |
| K043082 | The Tosca Anterior Cervical Plate System | 2004 | 3 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Spinal Concepts, Inc. (SCI) 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:
1. Degenerative disc disease (DDD) — 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/K990005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990005: Spinal Concepts, Inc. (Sci) 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/K990005
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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