510(k) Report

510(k) · Cleared

Cleared

Cardo Medical Anterior Cervical Plate System

K091396510(k) TraditionalCleared Aug 5, 200987-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

Cardo Medical Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 5, 2009 as substantially equivalent to K040003 (Vertebron, Inc., 2004) and 4 other predicates after an 87-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.

Decided
Aug 5, 2009
Review
87 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 10 generations to K922087 (1992). 33 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2002: 2 other ancestors2001: 3 other ancestors2000: 2 other ancestors1998: 5 other ancestors1997: 4 other ancestors1995: 1 other ancestor1999: 3 other ancestors1993: 2 other ancestors2017: 1 descendant cleared2019: 1 descendant 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. · 2002K030595 · Blackstone Fusion Anterior Cervical Plating System · Blackstone Medical, Inc. · 2003K040003 · Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2004K043181 · Modification to Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2004K051815 · Modification to Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2005K062110 · Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2006K073530 · Accin Anterior Cervical Plate System · Accelerated Innovation, LLC · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 12 other ancestors4 generations back: 8 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K073530 · Accin Anterior Cervical Plate System · Accelerated Innovation, LLC · 2008K062110 · Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2006K051815 · Modification to Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2005K043181 · Modification to Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2004K040003 · Vertebron SCP Cervical Plate System · Vertebron, Inc. · 2004K030595 · Blackstone Fusion Anterior Cervical Plating System · Blackstone Medical, Inc. · 2003K012184 · 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. · 1992−10−50
  1. Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 6 generations between
  3. 3 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  4. 2 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
  5. 1 generation backK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
  6. This deviceK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
  7. Descendant · cites it directly · 1 of its ownK163061 Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
  8. Descendant · 2 generations on · 0 of its ownK183084 Fuji Cervical Plate SystemAltus Partners, LLC · 2019
Show all 10 generations
  1. Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 9 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 8 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 7 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
  5. 6 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
  6. 5 generations backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  7. 4 generations backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  8. 3 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  9. 2 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
  10. 1 generation backK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
  11. This deviceK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K163061Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017 · cites it directly1descendant
  • K183084Fuji Cervical Plate SystemAltus Partners, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−9K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−8K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−7K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
−6K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.2003—
−5K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—
−4K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—
−3K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.2005—
−2K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.2006—
−1K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC2008—
0 (this device)K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.2009—
+1K163061Altus Spine Cervical Plate SystemAltus Partners, LLC2017—
+2K183084Fuji Cervical Plate SystemAltus Partners, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199510
199740
199850
199930
200020
200130
200220
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201910
FIG. 1 — Lineage of K091396, 1992–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K040003Vertebron SCP Cervical Plate System
Summary page 1
…liance, Fixation, Spinal Intervertebral Body, 21 CFR 880.3060, Class 11 Predicate Device: Vertebron Cervical Plate Systems - K040003, K0431 81, KO0i1815, K0621 10 and K081567. Cardo Medical Cervical Plate System K073530 Device Des…
Vertebron, Inc.2004—
*K043181Modification to Vertebron SCP Cervical Plate System
Summary page 1
…ixation, Spinal Intervertebral Body, 21 CFR 880.3060, Class 11 Predicate Device: Vertebron Cervical Plate Systems - K040003, K0431 81, KO0i1815, K0621 10 and K081567. Cardo Medical Cervical Plate System K073530 Device Description:…
Vertebron, Inc.2004—
Kept off the family treeK001815FDA’s K001815 is DC Zirkon
Our reading of the summary gave K001815, FDA’s number for DC Zirkon (Austenal, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vertebron Cervical Plate Systems”. Kept off the family tree.
Austenal, Inc.2000—
*K062110Vertebron SCP Cervical Plate System
Summary page 1
…rvertebral Body, 21 CFR 880.3060, Class 11 Predicate Device: Vertebron Cervical Plate Systems - K040003, K0431 81, KO0i1815, K0621 10 and K081567. Cardo Medical Cervical Plate System K073530 Device Description: The Cardo…
Vertebron, Inc.2006—
*K081567Vertebron SSP Cervical Plating System
Summary page 1
…Class 11 Predicate Device: Vertebron Cervical Plate Systems - K040003, K0431 81, KO0i1815, K0621 10 and K081567. Cardo Medical Cervical Plate System K073530 Device Description: The Cardo Medical Cervical Plate System consists of…
Vertebron, Inc.2008—
*K073530Accin Anterior Cervical Plate System
Summary page 1
…ce: Vertebron Cervical Plate Systems - K040003, K0431 81, KO0i1815, K0621 10 and K081567. Cardo Medical Cervical Plate System K073530 Device Description: The Cardo Medical Cervical Plate System consists of titanium cervical plates and…
Accelerated Innovation, LLC2008—

Also cleared against K040003: 5 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171

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 17 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 33 ancestors have a recall of any class.
  • Of its descendants, K163061 (Altus Partners, LLC, 2017) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K040003.

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. 2009, this device’s year, is highlighted.

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 Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with:

Degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

Trauma (including fractures)

Tumor

Deformity (defined as kyphosis, lordosis or scoliosis)

Pseudoarthrosis

Failed previous fusions.

The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Indications for use as stated in the FDA summary.

Also cleared against K040003

5 other devices cite the same predicate.

  • K163061Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
  • K081567Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
  • K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
  • K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  • K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004

More from Cardo Medical Corp.

3 FDA decisions under this applicant name. See the company

  • K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp. · 2010
  • K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp. · 2009

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/K091396 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091396: Cardo Medical 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/K091396

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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