510(k) Report

510(k) · Cleared

Cleared

ASCOT

K132310510(k) TraditionalCleared Dec 23, 2013151-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

Backroads Consulting, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 23, 2013 as substantially equivalent to K043082 (Signus Medizintechnik GmbH, 2004) and 4 other predicates after a 151-day review. Its family tree reaches back 9 generations to 1992.

Decided
Dec 23, 2013
Review
151 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
5

Its longest line of descent runs back 9 generations to K922087 (1992). 36 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2004: 2 other ancestors2002: 2 other ancestors2001: 3 other ancestors2000: 2 other ancestors1998: 5 other ancestors1997: 4 other ancestors1995: 2 other ancestors1992: 1 other ancestor1993: 2 other ancestors1999: 3 other ancestorsK922087 · 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. · 2006199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 9 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 5 other ancestors 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 deviceK132310 ASCOTBackroads Consulting, Inc. · 2013
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 deviceK132310 ASCOTBackroads Consulting, Inc. · 2013
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)K132310ASCOTBackroads Consulting, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199320
199520
199740
199850
199930
200020
200130
200220
200420
200810
FIG. 1 — Lineage of K132310, 1992–2013Source: 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? (5)

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
*K043082The Tosca Anterior Cervical Plate System
Summary page 1
…The ASCOr' implant components are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Predicate Devices: TOSCA® (K043082) TOSCA® 11(KO8O8iS) VERTEBRON SCP TM (K051815 & K0621 10) Uni…
Signus Medizintechnik GmbH2004—
*K080815Tosca II Anterior Cervical Plate SystemSignus Medizintechnik GmbH2008—
*K051815Modification to Vertebron SCP Cervical Plate System
Summary page 1
…alloy (Ti-6A1-4V ELI) as described by ASTM F136. Predicate Devices: TOSCA® (K043082) TOSCA® 11(KO8O8iS) VERTEBRON SCP TM (K051815 & K0621 10) Uniplate m (K042544) Performance Data: Mechanical testing of the worst case ASCOr was per…
Vertebron, Inc.2005—
*K062110Vertebron SCP Cervical Plate System
Summary page 1
…6A1-4V ELI) as described by ASTM F136. Predicate Devices: TOSCA® (K043082) TOSCA® 11(KO8O8iS) VERTEBRON SCP TM (K051815 & K0621 10) Uniplate m (K042544) Performance Data: Mechanical testing of the worst case ASCOr was performed…
Vertebron, Inc.2006—
*K042544Uniplate Anterior Cervical Plate System
Summary page 1
…ate Devices: TOSCA® (K043082) TOSCA® 11(KO8O8iS) VERTEBRON SCP TM (K051815 & K0621 10) Uniplate m (K042544) Performance Data: Mechanical testing of the worst case ASCOr was performed according to ASTM F1 717…
Depuy Spine, Inc.2004—

Also cleared against K043082: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 36 ancestors have a recall of any class.
  • 1 other device also cites its predicate K043082.

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. 2013, 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?

AsCorO is Intended for anterior cervical fixation (C2-C7) for the following Indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolistiiesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures 0.e., scollosis, kyphosis and/or lordosis). tumor, pseudarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K043082

1 other device cites the same predicate.

  • K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 20167 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/K132310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132310: ASCOT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132310

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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