510(k) Report

510(k) · Cleared

Cleared

GPS TM, G Surgical Anterior Cervical Plate System +

K103070510(k) TraditionalCleared Jan 12, 201186-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

G Surgical Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 12, 2011 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 2000.

Decided
Jan 12, 2011
Review
86 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K000536 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestorK000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalled2000200220042006200820102012
Other ancestors, by generation 1 generation back: 2 other ancestors K000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalled0
  1. Root · 1 generation backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
  2. This deviceK103070 GPS TM, G Surgical Anterior Cervical Plate System +G Surgical Co., Ltd. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000536Synthes Anterior CSLP SystemSynthes Spine20001
0 (this device)K103070GPS TM, G Surgical Anterior Cervical Plate System +G Surgical Co., Ltd.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
FIG. 1 — Lineage of K103070, 2000–2011Source: 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? (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 1
…requested indications. Device/Product Code(s): Anterior Cervical Plates (KWVQ) 21 CFR § 888.3060 Predicate Devices: K030866 Synthes CSLP April 18, 2003 K000536 Synthes CSLP May 15, 2000…
Synthes (Usa)2003—
*K000536Synthes Anterior CSLP System
Summary page 1
…es (KWVQ) 21 CFR § 888.3060 Predicate Devices: K030866 Synthes CSLP April 18, 2003 K000536 Synthes CSLP May 15, 2000 K021461 Medtronic Atlantis Vision® July 22, 20002 Device D…
Synthes Spine20001
*K021461Atlantis Vision Anterior Cervical Plate System
Summary page 1
…K030866 Synthes CSLP April 18, 2003 K000536 Synthes CSLP May 15, 2000 K021461 Medtronic Atlantis Vision® July 22, 20002 Device Description: The GPSTM G Surgical Anterior Cervical Plate System consists of a…
Medtronic Sofamor Danek20023

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?

  • 2 of the 3 ancestors have a recall of any class.
  • 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. 2011, 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 GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of the discogenic origin with degeneration of disc confirmed by patient…

Read the full statement (121 words)

The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications:

* Degenerative Disc Disease (as defined by neck pain of the discogenic origin with degeneration of disc confirmed by patient history and radiographic studies)

* Trauma (including fractures)

* Tumors

* Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

* Pseudarthrosis

* Failed previous fusion

* Spondylolisthesis

* Spinal Stenosis

Warning: This device is not approved for screw attachment or 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 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 G Surgical Co., Ltd.

2 FDA decisions under this applicant name. See the company

  • K081041GPS, G Surgical Pedicle SystemG Surgical Co., Ltd. · 2008

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/K103070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103070: GPS TM, G Surgical Anterior 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/K103070

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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