510(k) Report

510(k) · Cleared

Cleared

Vertebron SSP Cervical Plating System

K081567510(k) SpecialCleared Jul 3, 200829-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

Vertebron, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 3, 2008 as substantially equivalent to K062110 (Vertebron, Inc., 2006) and 3 other predicates after a 29-day review. Its family tree reaches back 9 generations to 1992. 6 later devices descend from it.

Decided
Jul 3, 2008
Review
29 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K922087 (1992). 31 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2001: 3 other ancestors2000: 2 other ancestors1998: 5 other ancestors1997: 4 other ancestors1995: 1 other ancestor1993: 2 other ancestors1999: 3 other ancestors2019: 2 descendants cleared2018: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2023: 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. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 9 other ancestors3 generations back: 8 other ancestors4 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K062110 · 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. · 1992−50
  1. Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 5 generations between
  3. 3 generations backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  4. 2 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  5. 1 generation backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
  6. This deviceK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
  7. Descendant · cites it directly · 2 of its ownK180022 Athena Cervical Plate SystemMedyssey USA, Inc. · 2018
  8. Descendant · cites it directly · 2 of its ownK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
  9. Descendant · cites it directly · 1 of its ownK183409 Athena II Cervical Plate SystemMedyssey USA, Inc. · 2019
  10. Descendant · 2 generations on · 1 of its ownK163061 Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
  11. Descendant · 2 generations on · 0 of its ownK230301 Athena III Cervical Plate SystemMedyssey USA, Inc. · 2023
Show all 9 generations
  1. Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 8 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 7 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 6 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
  5. 5 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
  6. 4 generations backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  7. 3 generations backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  8. 2 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  9. 1 generation backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
  10. This deviceK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12017: 12018: 12019: 22023: 1
2009high 2 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K180022Athena Cervical Plate SystemMedyssey USA, Inc. · 2018 · cites it directly2descendants
  • K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009 · cites it directly2descendants
  • K183409Athena II Cervical Plate SystemMedyssey USA, Inc. · 2019 · cites it directly1descendant
  • K163061Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017 · 2 generations on1descendant
  • K230301Athena III Cervical Plate SystemMedyssey USA, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−8K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−7K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−6K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
−5K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.2003—
−4K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—
−3K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—
−2K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.2005—
−1K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.2006—
0 (this device)K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.2008—
+1K180022Athena Cervical Plate SystemMedyssey USA, Inc.2018—
+1K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.2009—
+1K183409Athena II Cervical Plate SystemMedyssey USA, Inc.2019—
+2K163061Altus Spine Cervical Plate SystemAltus Partners, LLC2017—
+2K230301Athena III Cervical Plate SystemMedyssey USA, Inc.2023—

Other ancestors by year cleared

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201710
201810
201920
202310
FIG. 1 — Lineage of K081567, 1992–2023Source: 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
*K062110Vertebron SCP Cervical Plate System
Summary page 1
…hosis COMMON NAME: Cervical Plating System PROPRIETARY NAME: VERTEBRON SSP Cervical Plating System PREDICATE DEVICES: VERTEBRON SSP System K0621 10 and K051815 VERTEBRON SCP System K043181 and K040003 DEVICE DESCRIPTION: The modified VERTEBRON…
Vertebron, Inc.2006—
*K051815Modification to Vertebron SCP Cervical Plate System
Summary page 1
…NAME: Cervical Plating System PROPRIETARY NAME: VERTEBRON SSP Cervical Plating System PREDICATE DEVICES: VERTEBRON SSP System K0621 10 and K051815 VERTEBRON SCP System K043181 and K040003 DEVICE DESCRIPTION: The modified VERTEBRON SSP TM Cerv…
Vertebron, Inc.2005—
*K043181Modification to Vertebron SCP Cervical Plate System
Summary page 1
…Y NAME: VERTEBRON SSP Cervical Plating System PREDICATE DEVICES: VERTEBRON SSP System K0621 10 and K051815 VERTEBRON SCP System K043181 and K040003 DEVICE DESCRIPTION: The modified VERTEBRON SSP TM Cervical Plate System is comprised of…
Vertebron, Inc.2004—
*K040003Vertebron SCP Cervical Plate System
Summary page 1
…VERTEBRON SSP Cervical Plating System PREDICATE DEVICES: VERTEBRON SSP System K0621 10 and K051815 VERTEBRON SCP System K043181 and K040003 DEVICE DESCRIPTION: The modified VERTEBRON SSP TM Cervical Plate System is comprised of non-ste…
Vertebron, Inc.2004—

Also cleared against K062110: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182
K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092
K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191

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 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 31 ancestors have a recall of any class.
  • Of its descendants, K180022 (Medyssey USA, Inc., 2018) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K062110.

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. 2008, 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 VERTEBRON SSPTM Cervical Plate System is 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 disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The SSPTM Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

Indications for use as stated in the FDA summary.

Also cleared against K062110

3 other devices cite the same predicate.

  • K132310ASCOTBackroads Consulting, Inc. · 2013
  • K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
  • K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008

More from Vertebron, Inc.

11 FDA decisions under this applicant name. See the company

  • K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
  • K073502Vertebron VBR SystemVertebron, Inc. · 2008
  • K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
  • K062110Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
  • K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005

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/K081567 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081567: Vertebron SSP Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081567

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