510(k) · Cleared
ClearedHallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 4, 2010 as substantially equivalent to K050892 (Blackstone Medical, Inc., 2005) and 1 other predicate after a 61-day review. Its family tree reaches back 6 generations to 1992. 51 later devices descend from it.
- Decided
- May 4, 2010
- Review
- 61 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922087 (1992). 22 ancestors in all. 51 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 5 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 4 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 3 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 2 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 1 generation backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- This deviceK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- Descendant · cites it directly · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- Descendant · cites it directly · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · 2 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 15 of its ownK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · 3 generations on · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · cites it directly19descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · cites it directly18descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 2 generations on15descendants
- K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on15descendants
- K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −5 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −4 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −3 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −2 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −1 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| 0 (this device) | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| +1 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| +1 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +2 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | 2018 | — |
| +3 | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | K050892 | Hallmarktm Anterior Cervical Plate SystemSummary page 1…Orthopedic Device Panel Predicate Devices: Blackstone Hallmark Anterior Cervical Plate Systemn (K050892 SE 5/11/105) Life Spine Kiinetic-SL Anterior Cervical Plate System… | 2005 |
| * | K073479 | Kinetic-SL Anterior Cervical Plate SystemSummary page 1…(K050892 SE 5/11/105) Life Spine Kiinetic-SL Anterior Cervical Plate System (K073479 SE 1/9/28) Hal/rn ark Anterior Cervical Plate Systemn Mfodifcation - 510(k) Smnnia'y Page 1 of 2 === Pag… | 2008 |
What descends from it? (51)
See all 517 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142060 | Transom Anterior Cervical Plate | 2014 | 19 |
| K163104 | Terrace™ Anterior Cervical Plate System | 2017 | 18 |
| K121658 | Orthofix Acp (Anterior Cervical Plate System) | 2012 | 4 |
| K162638 | CETRA Anterior Cervical Plate System | 2016 | 3 |
| K122216 | Reliance Anterior Cervical Plate System | 2012 | 3 |
| K130825 | Azure Anterior Cervical Plate System | 2013 | 1 |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity… | 2022 | 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 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K142060 (Neurostructures, Inc., 2014) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K050892.
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 Hallmark Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Fracture;
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100614
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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