510(k) Report

510(k) · Cleared

Cleared

Global Spinal Fixation System

K001668510(k) TraditionalCleared Oct 19, 2000141-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

D.K.M. Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Oct 19, 2000 as substantially equivalent to K992147 (Advanced Spine Technology, Inc., 2000) after a 141-day review. Its family tree reaches back 1 generation to 2000. 450 later devices descend from it.

Decided
Oct 19, 2000
Review
141 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K992147 (2000). 450 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2012: 13 descendants cleared2010: 13 descendants cleared2007: 4 descendants cleared2011: 12 descendants cleared2004: 1 descendant cleared2005: 4 descendants cleared2003: 1 descendant cleared2013: 20 descendants cleared2008: 10 descendants cleared2009: 7 descendants cleared2014: 19 descendants cleared2016: 21 descendants cleared2024: 41 descendants cleared2017: 30 descendants cleared2019: 18 descendants cleared2015: 25 descendants cleared2022: 27 descendants cleared2021: 22 descendants cleared2018: 27 descendants cleared2020: 25 descendants cleared2023: 39 descendants cleared2026: 35 descendants cleared2025: 33 descendants clearedK992147 · Triple-Fix Spinal Fixation System · Advanced Spine Technology, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 16 descendants2 generations forward: 43 descendants3 generations forward: 63 descendants4 generations forward: 78 descendants5 generations forward: 72 descendants6 generations forward: 58 descendants7 generations forward: 47 descendants8 generations forward: 37 descendants9 generations forward: 19 descendants10 generations forward: 13 descendants11 generations forward: 4 descendants K992147 · Triple-Fix Spinal Fixation System · Advanced Spine Technology, Inc. · 20000+5+10
  1. Root · 1 generation backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
  2. This deviceK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
  3. Descendant · cites it directly · 181 of its ownK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
  4. Descendant · cites it directly · 180 of its ownK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
  5. Descendant · cites it directly · 179 of its ownK062513 Apex Spine SystemSpinecraft, Inc. · 2006
  6. Descendant · cites it directly · 179 of its ownK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
  7. Descendant · 2 generations on · 178 of its ownK092825 Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010

Showing 5 of 450 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 42006: 32007: 42008: 102009: 72010: 132011: 122012: 132013: 202014: 192015: 252016: 212017: 302018: 272019: 182020: 252021: 222022: 272023: 392024: 412025: 332026: 35
2003high 41 (2024) · low 1 (2003)2026

Most influential descendants

Showing 5 of 450 · See all
  • K053573GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006 · cites it directly181descendants
  • K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · cites it directly180descendants
  • K062513Apex Spine SystemSpinecraft, Inc. · 2006 · cites it directly179descendants
  • K031455Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003 · cites it directly179descendants
  • K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010 · 2 generations on178descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992147Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc.2000—
0 (this device)K001668Global Spinal Fixation SystemD.K.M. Co., Ltd.2000—
+1K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006—
+1K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041
+1K062513Apex Spine SystemSpinecraft, Inc.2006—
+1K031455Conklusion Pedicle Screw SystemSignus Medical, LLC2003—
+2K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200540
200630
200740
2008100
200970
2010130
2011120
2012130
2013200
2014190
2015250
2016210
2017300
2018270
2019180
2020250
2021220
2022270
2023390
2024410
2025330
2026350
FIG. 1 — Lineage of K001668, 2000–2026Source: 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K992147Triple-Fix Spinal Fixation System
Summary page 2
…: 82.2.921.6428 SUBSTANTIAL EQUIVALENCE The Global Spinal Fixation System is substantially equivalent to Advanced Spine Technology’s Triple-Fix Spinal Fixation System (K992147). DEVICE DESCRIPTION The Global Spinal Fixation System (GSFS) is a multiple component system comprised of a variety of single-u…
Advanced Spine Technology, Inc.2000—

Also cleared against K992147: 2 other devices →

What descends from it? (450)

See all 450

16 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006181
K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.2004180
K062513Apex Spine SystemSpinecraft, Inc.2006179
K031455Conklusion Pedicle Screw SystemSignus Medical, LLC2003179
K0607024CIS Vane Spine SystemSolco Biomedical Co., Ltd.2006166
K0504714CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.2005127
K043578The 4CIS Spinal System and 4CIS Low Back SystemSolco Biomedical Co., Ltd.2005125
K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2010124
K042928Modification to Global Spinal Fixation SystemU&I Corp.2005124
K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123

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?

  • Its one ancestor has no recall.
  • Of its descendants, K053573 (GS Medical Co., Ltd., 2006) has gone furthest, with 181 descendants of its own.
  • 2 other devices also cite its predicate K992147.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The Global Spinal Fixation System is a pedicle screw indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the GSFS is intended to provide immobilization and stabilization of spinal segments in…

Read the full statement (119 words)

The Global Spinal Fixation System is a pedicle screw indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the GSFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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 K992147

2 other devices cite the same predicate.

  • K042928Modification to Global Spinal Fixation SystemU&I Corp. · 2005
  • K031455Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K001668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001668: Global Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001668

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026