510(k) Report

510(k) · Cleared

Cleared

Modification to Vertebron SCP Cervical Plate System

K051815510(k) SpecialCleared Oct 17, 2005104-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 Oct 17, 2005 as substantially equivalent to K982443 (Depuy Motech Acromed, 1998) and 8 other predicates after a 104-day review. Its family tree reaches back 7 generations to 1992. 10 later devices descend from it.

Decided
Oct 17, 2005
Review
104 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
9

Its longest line of descent runs back 7 generations to K922087 (1992). 29 ancestors in all. 10 later devices descend from it, 4 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 ancestors2013: 1 descendant cleared2008: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2019: 2 descendants cleared2018: 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. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors4 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants K043181 · 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 · 7 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 6 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 5 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 4 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
  5. 3 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
  6. 2 generations backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  7. 1 generation backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  8. This deviceK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  9. Descendant · cites it directly · 9 of its ownK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
  10. Descendant · cites it directly · 6 of its ownK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
  11. Descendant · cites it directly · 3 of its ownK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
  12. Descendant · 2 generations on · 2 of its ownK180022 Athena Cervical Plate SystemMedyssey USA, Inc. · 2018
  13. Descendant · 2 generations on · 2 of its ownK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22009: 12013: 12017: 12018: 12019: 22023: 1
2006high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K062110Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006 · cites it directly9descendants
  • K081567Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008 · cites it directly6descendants
  • K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008 · cites it directly3descendants
  • K180022Athena Cervical Plate SystemMedyssey USA, Inc. · 2018 · 2 generations on2descendants
  • K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−6K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−5K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−4K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.2002—
−3K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.2003—
−2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—
−1K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—
0 (this device)K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.2005—
+1K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.2006—
+1K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.2008—
+1K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC2008—
+2K180022Athena Cervical Plate SystemMedyssey USA, Inc.2018—
+2K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.2009—

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
200610
200820
200910
201310
201710
201810
201920
202310
FIG. 1 — Lineage of K051815, 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? (9)

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
*K982443Doc Ventral Cervical Stabilization System
Summary page 1
…VERTEBRON SCP TM Cervical Plate System is substantially equivalent to the DOC Cervical Stabilization System (K982443), ORION Anterior Cervical Plate (K973854), Synthes CSLP (K971883, K000536), ABC…
Depuy Motech Acromed1998—
*K973854Orion Anterior Cervical Plate System
Summary page 1
…s substantially equivalent to the DOC Cervical Stabilization System (K982443), ORION Anterior Cervical Plate (K973854), Synthes CSLP (K971883, K000536), ABC…
Sofamor Danek USA,Inc.1998—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 1
…nt to the DOC Cervical Stabilization System (K982443), ORION Anterior Cervical Plate (K973854), Synthes CSLP (K971883, K000536), ABC 050 ===…
Synthes (Usa)19971
*K000536Synthes Anterior CSLP System
Summary page 1
…DOC Cervical Stabilization System (K982443), ORION Anterior Cervical Plate (K973854), Synthes CSLP (K971883, K000536), ABC 050 === Page 2 ==…
Synthes Spine20001
*K974706Aesculap Abc Cervical Plating System
Summary page 2
…CSLP (K971883, K000536), ABC 050 Cervical Plate (K974706), EBI VueLock Anterioer Cervical Plate (K010003, K023133) and VERTEBRON SCP TM Cervical Plate System (K040003 and K043181) which…
Aesculap, Inc.1998—
*K010003Ebi Vuelock Anterior Cervical Plate System
Summary page 2
…050 Cervical Plate (K974706), EBI VueLock Anterioer Cervical Plate (K010003, K023133) and VERTEBRON SCP TM Cervical Plate System (K040003 and K043181) which have received market clearance by the FDA.…
Ebi, L.P.2001—
*K023133Modification to Ebi Vuelock Anterior Cervical Plate System
Summary page 2
…050 Cervical Plate (K974706), EBI VueLock Anterioer Cervical Plate (K010003, K023133) and VERTEBRON SCP TM Cervical Plate System (K040003 and K043181) which have received market clearance by the FDA.…
Ebi, L.P.2002—
*K040003Vertebron SCP Cervical Plate System
Summary page 1
…g System PROPRIETARY NAME: VERTEBRON SCP TM Cervical Plate System PREDICATE DEVICES: VERTEBRON SCP MT Cervical Plate System - K040003 and K043181 DEVICE DESCRIPTION: The Reduced Stature VERTEBRON SCP TM Cervical Plate Syst…
Vertebron, Inc.2004—
*K043181Modification to Vertebron SCP Cervical Plate System
Summary page 1
…RTEBRON SCP TM Cervical Plate System PREDICATE DEVICES: VERTEBRON SCP MT Cervical Plate System - K040003 and K043181 DEVICE DESCRIPTION: The Reduced Stature VERTEBRON SCP TM Cervical Plate System is compri…
Vertebron, Inc.2004—

Also cleared against K982443: 6 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069
K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086
K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083
K132310ASCOTBackroads Consulting, Inc.20130

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 13 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 29 ancestors have a recall of any class.
  • Of its descendants, K062110 (Vertebron, Inc., 2006) has gone furthest, with 9 descendants of its own.
  • 6 other devices also cite its predicate K982443.

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 VERTEBRON SCP TM 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), pseudoarthriosis, and/or failed previous fusions. The SCP TM 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 K982443

6 other devices cite the same predicate.

  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  • K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012
  • K073500Active Anterior Cervical Plate SystemSanacor · 2008
  • K071990Valeo Cervical Plate SystemAmedica Corp. · 2007
  • K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005

More from Vertebron, Inc.

11 FDA decisions under this applicant name. See the company

  • K081567Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
  • 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

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/K051815 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051815: Modification to Vertebron SCP Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051815

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