510(k) · Cleared
ClearedBlackstone Medical Inc. Anterior Cervical Plate 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 Jun 17, 1998 after a 169-day review. The FDA summary names its predicate without a number. 296 later devices descend from it.
- Decided
- Jun 17, 1998
- Review
- 169 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
296 later devices descend from it, 10 citing it directly.
- This deviceK974885 Blackstone Medical Inc. Anterior Cervical Plate SystemBlackstone Medical, Inc. · 1998
- Descendant · cites it directly · 289 of its ownK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- Descendant · 2 generations on · 145 of its ownK050813 Abc 2 ScrewAesculap, Inc. · 2005
- Descendant · 3 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
- Descendant · 4 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 2 generations on · 101 of its ownK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
Showing 5 of 296 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 296 · See all- K000486Abc Cervical Plating SystemAesculap, Inc. · 2000 · cites it directly289descendants
- K050813Abc 2 ScrewAesculap, Inc. · 2005 · 2 generations on145descendants
- K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 3 generations on132descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 4 generations on106descendants
- K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012 · 2 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974885 | Blackstone Medical Inc. Anterior Cervical Plate System | Blackstone Medical, Inc. | 1998 | — |
| +1 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| +2 | K050813 | Abc 2 Screw | Aesculap, Inc. | 2005 | — |
| +3 | K133475 | Struxxure Anterior Cervical Plate and Screws | Nexxt Spine, LLC | 2013 | — |
| +4 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +2 | K122910 | Archon Anterior Cervical Plate Syste, | Nu Vasive, Incorporated | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 17 | 0 |
| 2020 | 24 | 0 |
| 2021 | 17 | 0 |
| 2022 | 25 | 0 |
| 2023 | 32 | 0 |
| 2024 | 35 | 0 |
| 2025 | 39 | 0 |
| 2026 | 36 | 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 |
|---|---|---|---|
| * | — | CODMAN Anterior Cervical Plate System Named without a submission number | |
| * | — | SYNTHES Cervical Locking Plate System Named without a submission number | |
| * | — | SOFAMOR DANEK ORION Anterior Cervical Plate System Named without a submission number |
What descends from it? (296)
See all 29610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K000486 | Abc Cervical Plating System | 2000 | 289 |
| K012184 | Blackstone Iii Anterior Cervical Plating System | 2002 | 85 |
| K142060 | Transom Anterior Cervical Plate | 2014 | 19 |
| K083338 | Cardiff Anterior Cervical Plate System | 2009 | 16 |
| K022965 | Blackstone Classic Anterior Cervical Plate | 2003 | 10 |
| K113170 | Cervical Plate | 2012 | 1 |
| K020620 | Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer) | 2002 | 1 |
| K110990 | Gso ACP1 Anterior Cervical Plate System | 2011 | 0 |
| K022798 | Cervive Anterior Cervical Plating System, Model Number 157.XXX Series Catalogue Numbers | 2002 | 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?
- Of its descendants, K000486 (Aesculap, Inc., 2000) has gone furthest, with 289 descendants of its own.
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?
The BLACKSTONE MEDICAL, INC. Anterior Cervical Plate System is to be used for anterior screw fixation of the cervical spine (C2-C7). The indications are as follows:
Indications:
Degenerative Disc Disease (ddd)*
*Back pain of discogenic origin with degeneration of the disc as confirmed by history and radiographic studies.
Spondylolisthesis
Fracture
Spinal Stenosis
Deformities (i.e., scoliosis, kyphosis, lordosis)
Tumor
Pseudoarthrosis
Revision of previous failed fusion 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/K974885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974885: Blackstone Medical Inc. Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974885
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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