510(k) · Cleared
ClearedDiamond Anterior 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 May 13, 2010 as substantially equivalent to K041469 (X-Spine Systems, 2004) and 2 other predicates after a 104-day review. Its family tree reaches back 2 generations to 1979. 34 later devices descend from it.
- Decided
- May 13, 2010
- Review
- 104 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792352 (1979). 6 ancestors in all. 34 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK792352 Synthes Cervical Vertabrae PlatesDePuy Synthes · 1979
- 1 generation backK042499 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- This deviceK100265 Diamond Anterior Cervical Plate SystemAmendia, Inc. · 2010
- Descendant · cites it directly · 28 of its ownK113329 K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 21 of its ownK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013
- Descendant · 3 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · 4 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 5 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012 · cites it directly28descendants
- K130202Iris Anterior Cervical PlateLife Spine, Inc. · 2013 · 2 generations on21descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 3 generations on18descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 4 generations on15descendants
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792352 | Synthes Cervical Vertabrae Plates | DePuy Synthes | 1979 | — |
| −1 | K042499 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K100265 | Diamond Anterior Cervical Plate System | Amendia, Inc. | 2010 | — |
| +1 | K113329 | K2M, Pyrenees Cervical Plate System | K2m, Inc. | 2012 | — |
| +2 | K130202 | Iris Anterior Cervical Plate | Life Spine, Inc. | 2013 | — |
| +3 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +4 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +5 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K041469 | Anterior Compact SystemSummary page 1…range in sizes from 12 mm to 18 mm and come in diameters of 4.0mm and 4.3mm. Predicate Device(s): Predicate devices previously cleared by FDA include the X-Spine ACP (K041469), the Synthes CSLP (K000536) and the Medtronic Orion Anterior Cervical Plate System K042499).… | 2004 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 1…o 18 mm and come in diameters of 4.0mm and 4.3mm. Predicate Device(s): Predicate devices previously cleared by FDA include the X-Spine ACP (K041469), the Synthes CSLP (K000536) and the Medtronic Orion Anterior Cervical Plate System K042499).… | 2000 |
| * | K042499 | Orion Anterior Cervical Plating SystemSummary page 1…vice(s): Predicate devices previously cleared by FDA include the X-Spine ACP (K041469), the Synthes CSLP (K000536) and the Medtronic Orion Anterior Cervical Plate System K042499). xitoi&69 Pogct/z… | 2004 |
What descends from it? (34)
See all 344 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 31 years and passes through 3 companies; a new generation was cleared every 24.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K113329 (K2m, Inc., 2012) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K041469.
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. 2010, 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 Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-Tl. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic…
Read the full statement (117 words)
The Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-Tl. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
* 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)
* Tumors
* Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
* Pseudarthrosis
* Failed previous fusion
* Spondylolisthesis
* Spinal Stenosis.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100265: Diamond 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/K100265
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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