510(k) · Cleared
ClearedBlackstone Iii Anterior Cervical Plating System
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 Jan 30, 2002 as substantially equivalent to K000486 (Aesculap, Inc., 2000) and 3 other predicates after a 202-day review. Its family tree reaches back 3 generations to 1992. 85 later devices descend from it.
- Decided
- Jan 30, 2002
- Review
- 202 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K922087 (1992). 13 ancestors in all. 85 later devices descend from it, 9 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 deviceK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- Descendant · cites it directly · 66 of its ownK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- Descendant · cites it directly · 52 of its ownK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 51 of its ownK100614 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 · 3 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003 · cites it directly66descendants
- K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · cites it directly52descendants
- K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · 2 generations on51descendants
- K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · cites it directly19descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 3 generations on18descendants
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) | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| +1 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| +1 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| +2 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| +1 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| +3 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K000486 | Abc Cervical Plating SystemSummary page 1…vice Product Code KWQ 888.3060 - Spinal Intervertebral Body Fixation & Classification: Orthosis Substantially Equivalent Devices: Aesculap® ABC Cervical Plating System (K000486) Blackstone™ Anterior Cervical Plate System (K974885) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971… | 2000 |
| * | K974885 | Blackstone Medical Inc. Anterior Cervical Plate SystemSummary page 1…l Body Fixation & Classification: Orthosis Substantially Equivalent Devices: Aesculap® ABC Cervical Plating System (K000486) Blackstone™ Anterior Cervical Plate System (K974885) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) Danek ZEPHIR™ Anterior Cervical Plate System (K9… | 1998 |
| * | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSummary page 1…sculap® ABC Cervical Plating System (K000486) Blackstone™ Anterior Cervical Plate System (K974885) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) Danek ZEPHIR™ Anterior Cervical Plate System (K994239) Device Description: The Blackstone™ III° Anterior Cervical Plating Syst… | 1997 |
| * | K994239 | Zephir Anterior Cervical Plate SystemSummary page 1…e™ Anterior Cervical Plate System (K974885) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) Danek ZEPHIR™ Anterior Cervical Plate System (K994239) Device Description: The Blackstone™ III° Anterior Cervical Plating System is a titanium alloy; multiple component system compr… | 2000 |
What descends from it? (85)
See all 859 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030595 | Blackstone Fusion Anterior Cervical Plating System | 2003 | 66 |
| K050892 | Hallmarktm Anterior Cervical Plate System | 2005 | 52 |
| K142060 | Transom Anterior Cervical Plate | 2014 | 19 |
| K022965 | Blackstone Classic Anterior Cervical Plate | 2003 | 10 |
| K131200 | Aspiron Acp System | 2013 | 7 |
| K140234 | Aspiron Acp System | 2014 | 6 |
| K020620 | Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer) | 2002 | 1 |
| K200523 | Biolign® Roto-Loc Cervical Plate System | 2020 | 0 |
| K020600 | Blackstone Iii Anterior Cervical Plating System (Plate Washer) | 2002 | 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 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K030595 (Blackstone Medical, Inc., 2003) has gone furthest, with 66 descendants of its own.
- 8 other devices also cite its predicate K000486.
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?
Blackstone™ III° Anterior Cervical Plating 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) pseudarthrosis;
h) revision of previous surgery
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012184: Blackstone Iii Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012184
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026