510(k) Report

510(k) · Cleared

Cleared

Blackstone Fusion Anterior Cervical Plating System

K030595510(k) TraditionalCleared Apr 24, 200358-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Blackstone Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 24, 2003 as substantially equivalent to K012184 (Blackstone Medical, Inc., 2002) and 3 other predicates after a 58-day review. Its family tree reaches back 4 generations to 1992. 66 later devices descend from it.

Decided
Apr 24, 2003
Review
58 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K922087 (1992). 14 ancestors in all. 66 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1997: 1 other ancestor1999: 3 other ancestors1998: 3 other ancestors1995: 1 other ancestor1993: 1 other ancestor2016: 1 descendant cleared2022: 4 descendants cleared2005: 2 descendants cleared2014: 2 descendants cleared2004: 2 descendants cleared2008: 2 descendants cleared2017: 3 descendants cleared2009: 1 descendant cleared2013: 2 descendants cleared2012: 2 descendants cleared2010: 1 descendant cleared2020: 4 descendants cleared2018: 2 descendants cleared2019: 5 descendants cleared2024: 6 descendants cleared2006: 1 descendant cleared2015: 1 descendant cleared2021: 3 descendants cleared2023: 5 descendants cleared2026: 8 descendants cleared2025: 9 descendants clearedK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K012184 · Blackstone Iii Anterior Cervical Plating System · Blackstone Medical, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 13 descendants4 generations forward: 10 descendants5 generations forward: 8 descendants6 generations forward: 12 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K012184 · Blackstone Iii Anterior Cervical Plating System · Blackstone Medical, Inc. · 2002K000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 19920+5
  1. Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 2 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 1 generation backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
  5. This deviceK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
  6. Descendant · cites it directly · 52 of its ownK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
  7. Descendant · 2 generations on · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
  8. Descendant · cites it directly · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
  9. Descendant · 3 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  10. Descendant · 4 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 12008: 22009: 12010: 12012: 22013: 22014: 22015: 12016: 12017: 32018: 22019: 52020: 42021: 32022: 42023: 52024: 62025: 92026: 8
2004high 9 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 66 · See all
  • 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
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−3K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−2K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−1K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
0 (this device)K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.2003—
+1K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.20052
+2K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.2010—
+1K142060Transom Anterior Cervical PlateNeurostructures, Inc.2014—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+4K190016Lateral Plate SystemCorelink, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199710
199830
199930
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200610
200820
200910
201010
201220
201320
201420
201510
201610
201730
201820
201950
202040
202130
202240
202350
202460
202590
202680
FIG. 1 — Lineage of K030595, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
*K000486Abc Cervical Plating System
Summary page 1
…stantially Equivalent Devices: BlackstoneTM 111' Anterior Cervical Plating System. (KO12184) AesculapB ABC Cervical Plating System (K000486) Synthes Spine Small Stature Anterior Cervical Vertebrae…
Aesculap, Inc.2000—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 1
…al Plating System (K000486) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) Danek ZEPHIRTM Anterior Cervical Plate System (IK994239) Device Description: The Blackstone…
Synthes (Usa)19971
*K994239Zephir Anterior Cervical Plate System
Summary page 1
…rior Cervical Vertebrae Plate System (K971883) Danek ZEPHIRTM Anterior Cervical Plate System (IK994239) Device Description: The Blackstone Fusion Cervical Plating System is a titanium alloy, multiple component system comprised o…
Medtronic Sofamor Danek, Inc.2000—

Also cleared against K012184: 8 other devices →

What descends from it? (66)

See all 66

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.200552
K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419
K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412
K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163
K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220

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, K050892 (Blackstone Medical, Inc., 2005) has gone furthest, with 52 descendants of its own.
  • 8 other devices also cite its predicate K012184.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The BlackstoneTMFusion Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from the C2 to C7. The specific 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.

Also cleared against K012184

8 other devices cite the same predicate.

  • K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd. · 2020
  • K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K131200Aspiron Acp SystemU&I Corporation · 2013
  • K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 20052 recalls
  • K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc. · 2003

More from Blackstone Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010
  • K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 20091 recall
  • K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
  • K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 20083 recalls

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K030595 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030595: Blackstone Fusion Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030595

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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