510(k) Report

510(k) · Cleared

Cleared

Mediant Anterior Cervical Plating System

K173935510(k) TraditionalCleared Apr 16, 2018111-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

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

Cleared on Apr 16, 2018 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 2 other predicates after a 111-day review. Its family tree reaches back 1 generation to 1995.

Decided
Apr 16, 2018
Review
111 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K945700 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestorK945700 · Synthes (Usa) Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1995199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors K945700 · Synthes (Usa) Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 19950
  1. Root · 1 generation backK945700 Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1995
  2. This deviceK173935 Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945700Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSynthes (Usa)1995—
0 (this device)K173935Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
FIG. 1 — Lineage of K173935, 1995–2018Source: 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
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What was it cleared against? (3)

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
*K030866Synthes Anterior CSLP System
Summary page 4
…ral Body Fixation Orthosis (21 CFR 888.3060) Regulatory Class: II Product Codes: KWQ III. Predicate Devices Primary Predicate: Synthes Spine Anterior CSLP System (K030866, K945700) Additional Predicate: Spinal Innovations SPECTRUM™ Cervical Spinal System (K022997) IV. Device Description The…
Synthes (Usa)2003—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 4
…Fixation Orthosis (21 CFR 888.3060) Regulatory Class: II Product Codes: KWQ III. Predicate Devices Primary Predicate: Synthes Spine Anterior CSLP System (K030866, K945700) Additional Predicate: Spinal Innovations SPECTRUM™ Cervical Spinal System (K022997) IV. Device Description The Intellig…
Synthes (Usa)1995—
*K022997Spectrum Cervical Spinal System
Summary page 4
…Predicate Devices Primary Predicate: Synthes Spine Anterior CSLP System (K030866, K945700) Additional Predicate: Spinal Innovations SPECTRUM™ Cervical Spinal System (K022997) IV. Device Description The Intelligent Implant Systems’ Mediant™ Anterior Cervical Plating System consists of bone screws…
Spinal Innovations, LLC2002—

Also cleared against K030866: 41 other devices →

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?

  • None of the 3 ancestors has a recall.
  • 41 other devices also cite its predicate K030866.

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. 2018, 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 Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K030866

41 other devices cite the same predicate.

  • K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
  • K201587icotec Anterior Cervical Plate SystemIcotec AG · 2020
  • K200883CarboClear® Cervical Plate SystemCarboFix Orthopedics, Ltd. · 2020
  • K192049Oryx Cervical Plate SystemInnovasis, Inc. · 20191 recall
  • K191500NuVasive® ACP SystemNu Vasive, Incorporated · 2019
  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019

More from Intelligent Implant Systems, LLC

6 FDA decisions under this applicant name. See the company

  • K163056Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017
  • K160216Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016
  • K142939Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015
  • K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC · 2013
  • K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC · 2012

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/K173935 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173935: Mediant Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173935

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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