510(k) · Cleared
ClearedEagle + Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 9, 2007 as substantially equivalent to K040197 (Depuyacromed, 2004) after a 30-day review. Its family tree reaches back 2 generations to 1997. 204 later devices descend from it.
- Decided
- May 9, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971730 (1997). 204 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 1 generation backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
- This deviceK070994 Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- Descendant · cites it directly · 195 of its ownK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- Descendant · cites it directly · 193 of its ownK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- Descendant · 2 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
- Descendant · 3 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 4 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 204 · See all- K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · cites it directly195descendants
- K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · cites it directly193descendants
- K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 2 generations on132descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 3 generations on106descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 4 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −1 | K040197 | Eagle Anterior Cervial Plate System | Depuyacromed | 2004 | — |
| 0 (this device) | K070994 | Eagle + Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| +1 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| +1 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| +2 | K133475 | Struxxure Anterior Cervical Plate and Screws | Nexxt Spine, LLC | 2013 | — |
| +3 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +4 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 12 | 0 |
| 2020 | 18 | 0 |
| 2021 | 12 | 0 |
| 2022 | 17 | 0 |
| 2023 | 26 | 0 |
| 2024 | 27 | 0 |
| 2025 | 29 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K040197 | Eagle Anterior Cervial Plate SystemSummary page 1…Orthosis PROPRIETARY NAME: EAGLETM + Anterior Cervical Plate System PREDICATE DEVICES: EAGLE T m Anterior Cervical Plate System (K0401 97) DEVICE DESCRIPTION: The EAGLE + Anterior Cervical Plate System consists of an assortment of plates… | 2004 |
What descends from it? (204)
See all 2044 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 10 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072546 (Depuy Spine, Inc., 2007) has gone furthest, with 195 descendants of its own.
- 4 other devices also cite its predicate K040197.
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. 2007, this device’s year, is highlighted.
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 EAGLETM + Anterior Cervical Plate 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, 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 as stated in the FDA summary.
https://510kreport.com/device/K070994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070994: Eagle + Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070994
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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