510(k) Report

510(k) · Cleared

Cleared

Quintex Cervical Plating System

K121801510(k) TraditionalCleared Sep 11, 201284-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

Aesculap Implant Systems, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 11, 2012 as substantially equivalent to K100243 (Aesculap Implant Systems, LLC, 2010) after an 84-day review. Its family tree reaches back 5 generations to 1992.

Decided
Sep 11, 2012
Review
84 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K922087 (1992). 20 ancestors in all, the oldest K913730 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2002: 1 other ancestor1998: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 1 other ancestor1999: 4 other ancestors1993: 1 other ancestorK922087 · 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. · 2000K040017 · Abc Caudal and Cranial Extension Plate (E-Plate) · Aesculap, Inc. · 2004K100243 · Quintex Cervical Plating System · Aesculap Implant Systems, LLC · 2010 · recalled19901995200020052010
Other ancestors, by generation 2 generations back: 7 other ancestors3 generations back: 5 other ancestors4 generations back: 3 other ancestors K100243 · Quintex Cervical Plating System · Aesculap Implant Systems, LLC · 2010 · recalledK040017 · Abc Caudal and Cranial Extension Plate (E-Plate) · Aesculap, Inc. · 2004K000486 · 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 · 5 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 4 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 3 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 2 generations backK040017 Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc. · 2004
  5. 1 generation backK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · Recalled
  6. This deviceK121801 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−4K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−3K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−2K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.2004—
−1K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC20101
0 (this device)K121801Quintex Cervical Plating SystemAesculap Implant Systems, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199410
199520
199830
199940
200210
200520
FIG. 1 — Lineage of K121801, 1992–2012Source: 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? (1)

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
*K100243Quintex Cervical Plating System
Summary page 1
…ap lmplanf-SstemW_(AIS), Inc., believes that the modifications to Quintex Cervical Plating System is substantially equivalent to the AIS Quintex Cervical Plating System (K1 00243). DEVICE..DESCRIPTION The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constraine…
Aesculap Implant Systems, LLC20101

Also cleared against K100243: 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 20 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
  • 2 of the 20 ancestors have a recall of any class.
  • 1 other device also cites its predicate K100243.

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. 2012, 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 Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from: *Degenerative disc disease (DOD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), *Spondylolisthesis, *Trauma (i.e. fracture or dislocation), *Spinal Stenosis, *Deformity (i.e., scoliosis, kyphosis, and/or lordosis), *Tumors, *Pseudoarthrosis as a result of failed spine…

Read the full statement (113 words)

The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:

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

*Spondylolisthesis,

*Trauma (i.e. fracture or dislocation),

*Spinal Stenosis,

*Deformity (i.e., scoliosis, kyphosis, and/or lordosis),

*Tumors,

*Pseudoarthrosis as a result of failed spine surgery,

*Failed previous fusions,

*Symptomatic cervical spondylosis

*Instability following surgery for the above indications.

Levels of anterior cervical intervertebrall body screw fixation for this indication are from Cr-Ti.

Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K100243

1 other device cites the same predicate.

  • K141993Nakoma AcpAlliance Partners, LLC · 20141 recall

More from Aesculap Implant Systems, LLC

22 FDA decisions under this applicant name. See the company

  • K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC · 2022
  • K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
  • K180433Ennovate®Aesculap Implant Systems, LLC · 20181 recall
  • K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  • K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC · 2016

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/K121801 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121801: Quintex 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/K121801

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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