510(k) · Cleared
ClearedAbc Caudal and Cranial Extension Plate (E-Plate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 14, 2004 as substantially equivalent to K974706 (Aesculap, Inc., 1998) and 3 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1992. 13 later devices descend from it.
- Decided
- May 14, 2004
- Review
- 129 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K922087 (1992). 12 ancestors in all. 13 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 backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- This deviceK040017 Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK141993 Nakoma AcpAlliance Partners, LLC · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 4 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · cites it directly10descendants
- K141993Nakoma AcpAlliance Partners, LLC · 2014 · 2 generations on8descendants
- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 3 generations on3descendants
- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 4 generations on2descendants
- K173128Alamo® CAlliance Partners, LLC · 2018 · 3 generations on2descendants
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 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| 0 (this device) | K040017 | Abc Caudal and Cranial Extension Plate (E-Plate) | Aesculap, Inc. | 2004 | — |
| +1 | K100243 | Quintex Cervical Plating System | Aesculap Implant Systems, LLC | 2010 | 1 |
| +2 | K141993 | Nakoma Acp | Alliance Partners, LLC | 2014 | 1 |
| +3 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +4 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +3 | K173128 | Alamo® C | Alliance Partners, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K974706 | Aesculap Abc Cervical Plating SystemSummary page 1…C Cervical Extension Plate is used to extend the existing anterior stabilization plate which was cleared through the Anterior Cervical Spine Plates and Screws (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486). The ABC E-Plates are exclusively used to extend an exis… | 1998 |
| * | K000486 | Abc Cervical Plating SystemSummary page 1…stabilization plate which was cleared through the Anterior Cervical Spine Plates and Screws (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486). The ABC E-Plates are exclusively used to extend an existing anterior stabilization plate on the cervical spine, whic… | 2000 |
| * | K992344 | Osteonics Accp System Line ExtensionSummary page 2…Fixation System (K000486) and the following other predicate devices: Osteonics Anterior Cervical Compression Plating System, Line Extension - Howmedica Osteonics Corp. (K992344). Osteonics Anterior Cervical Compression Plating System, Cortical Screws - Howmedica Osteonics Corp. (K993181).… | 1999 |
| * | K993181 | Howmedica Osteonics Accp System Cortical ScrewsSummary page 2…lating System, Line Extension - Howmedica Osteonics Corp. (K992344). Osteonics Anterior Cervical Compression Plating System, Cortical Screws - Howmedica Osteonics Corp. (K993181). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1999 |
What descends from it? (13)
See all 132 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)
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 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K100243 (Aesculap Implant Systems, LLC, 2010) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K974706.
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 ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies)., trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from…
Read the full statement (106 words)
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies)., trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040017: Abc Caudal and Cranial Extension Plate (E-Plate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040017
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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