510(k) · Cleared
ClearedBlackstone Classic Anterior Cervical Plate
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 Mar 28, 2003 as substantially equivalent to K012184 (Blackstone Medical, Inc., 2002) and 1 other predicate after a 203-day review. Its family tree reaches back 4 generations to 1992. 10 later devices descend from it.
- Decided
- Mar 28, 2003
- Review
- 203 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922087 (1992). 14 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 2 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 1 generation backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- This deviceK022965 Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK161524 Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK210424 Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK252611 aprevo® cervical plating systemCarlsmed, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK260570 corra™ cervical plating systemCarlsmed, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC · 2016 · cites it directly8descendants
- K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc. · 2021 · 2 generations on4descendants
- K252611aprevo® cervical plating systemCarlsmed, Inc. · 2025 · 3 generations on3descendants
- K260570corra™ cervical plating systemCarlsmed, Inc. · 2026 · 4 generations on1descendant
- K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −3 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −2 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −1 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| 0 (this device) | K022965 | Blackstone Classic Anterior Cervical Plate | Blackstone Medical, Inc. | 2003 | — |
| +1 | K161524 | Tangis Anterior Cervical Plate | Nvision Biomedical Technologies, LLC | 2016 | — |
| +2 | K210424 | Quantum Anterior Cervical Plate | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +3 | K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025 | — |
| +4 | K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026 | — |
| +2 | K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K012184 | Blackstone Iii Anterior Cervical Plating SystemSummary page 1…- Spinal Intervertebral Body Fixation & Classification: Orthosis Substantially Equivalent Devices: BlackstoneTM111” Anterior Cervical Plating System (K012184) BlackstoneTMAnterior Cervical Plate System (K974885) Device Description: The BlackstoneTM “Classic” Anterior Cervical Pla… | 2002 |
| * | K974885 | Blackstone Medical Inc. Anterior Cervical Plate SystemSummary page 1…Orthosis Substantially Equivalent Devices: BlackstoneTM111” Anterior Cervical Plating System (K012184) BlackstoneTMAnterior Cervical Plate System (K974885) Device Description: The BlackstoneTM “Classic” Anterior Cervical Plate is a titanium alloy; multiple component system comprised… | 1998 |
What descends from it? (10)
2 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 11 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K161524 (Nvision Biomedical Technologies, LLC, 2016) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K012184.
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?
BlackstoneTM111" 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 as stated in the FDA summary.
https://510kreport.com/device/K022965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022965: Blackstone Classic Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022965
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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