510(k) · Cleared
ClearedAmendia Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 15, 2015 as substantially equivalent to K130030 (Zavation, LLC, 2013) after a 48-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Oct 15, 2015
- Review
- 48 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K971730 (1997). 21 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 5 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- 4 generations backK042317 Cervical PlateScient'X · 2004
- 3 generations backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
- 2 generations backK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- 1 generation backK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
- This deviceK152455 Amendia Cervical Plate SystemAmendia, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK231593 Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −5 | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| −4 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| −3 | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | 1 |
| −2 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| −1 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
| 0 (this device) | K152455 | Amendia Cervical Plate System | Amendia, Inc. | 2015 | — |
| +1 | K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K130030 | Zavation Cervical Plate SystemSummary page 4…bral body fixation orthosis Device Product Code and Classification: KWQ, Class II (§888.3060) Primary Predicate: Zavation Cervical Plate System (K130030) Device Description: The Amendia Cervical Plate System is a multiple component system comprised of non-sterile, single-use impla… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231593 | Sapphire X3 Anterior Cervical Plate System | 2023 | 0 |
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 18 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K231593 (Spinal Elements, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K130030.
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. 2015, 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 Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152455: Amendia 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/K152455
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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