510(k) Report

510(k) · Cleared

Cleared

MVP Cervical Plate System

K190170510(k) TraditionalCleared May 13, 2019101-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

GS Medical Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 13, 2019 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 2 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1997.

Decided
May 13, 2019
Review
101 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K971730 (1997). 8 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2003: 1 other ancestor2004: 1 other ancestor1992: 1 other ancestorK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 1997K040197 · Eagle Anterior Cervial Plate System · Depuyacromed · 2004K082273 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 2008K100070 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 20101990199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor K100070 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 2010K082273 · Uniplate Anterior Cervical Plate System · Depuy Spine, Inc. · 2008K040197 · Eagle Anterior Cervial Plate System · Depuyacromed · 2004K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19970
  1. Root · 4 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. 3 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  3. 2 generations backK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
  4. 1 generation backK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
  5. This deviceK190170 MVP Cervical Plate SystemGS Medical Co., Ltd. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
−3K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004—
−2K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2008—
−1K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.2010—
0 (this device)K190170MVP Cervical Plate SystemGS Medical Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
200310
200410
200810
FIG. 1 — Lineage of K190170, 1997–2019Source: 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? (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 5
…well as associated instruments. GS Medical believes that the MVP Cervical Plate System is substantially equivalent to the following: • Synthes Anterior CSLP System (K030866) – primary • NUVASIVE HELIX MINI ACP SYSTEM (K073275) -- additional • Depuy UNIPLATE 2 Anterior Cervical Plate System (K1…
Synthes (Usa)2003—
*K073275Nuvasive Helix Mini Acp System
Summary page 5
…the MVP Cervical Plate System is substantially equivalent to the following: • Synthes Anterior CSLP System (K030866) – primary • NUVASIVE HELIX MINI ACP SYSTEM (K073275) -- additional • Depuy UNIPLATE 2 Anterior Cervical Plate System (K100070) - additional Intended Use / Indications for Use…
Nuvasive, Inc.2008—
*K100070Uniplate Anterior Cervical Plate System
Summary page 5
…• Synthes Anterior CSLP System (K030866) – primary • NUVASIVE HELIX MINI ACP SYSTEM (K073275) -- additional • Depuy UNIPLATE 2 Anterior Cervical Plate System (K100070) - additional Intended Use / Indications for Use The MVP Cervical Plate System is intended for anterior cervical fixation (C2…
Depuy Spine, Inc.2010—

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?

  • The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
  • None of the 8 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. 2019, 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 MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications:

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

• Spondylolisthesis

• Trauma (including fracture or dislocation)

• Spinal Stenosis

• Deformities or curvatures (kyphosis, lordosis, or scoliosis)

• Tumors

• Pseudoarthrosis

• Failed Previous Fusion

Indications for use as stated in the FDA summary.

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 GS Medical Co., Ltd.

20 FDA decisions under this applicant name. See the company

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
  • K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd. · 2024
  • K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd. · 2024
  • K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2024

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/K190170 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190170: MVP Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190170

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