510(k) Report

510(k) · Cleared

Cleared

Conklusion Pedicle Screw System

K031455510(k) TraditionalCleared Oct 22, 2003168-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

Signus Medical, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 22, 2003 as substantially equivalent to K022271 (Spine Vision, Inc., 2002) and 2 other predicates after a 168-day review. Its family tree reaches back 2 generations to 2000. 179 later devices descend from it.

Decided
Oct 22, 2003
Review
168 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K992147 (2000). 3 ancestors in all. 179 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2007: 2 descendants cleared2008: 5 descendants cleared2010: 4 descendants cleared2011: 5 descendants cleared2012: 1 descendant cleared2009: 1 descendant cleared2013: 7 descendants cleared2016: 7 descendants cleared2022: 14 descendants cleared2015: 7 descendants cleared2014: 4 descendants cleared2020: 7 descendants cleared2019: 4 descendants cleared2021: 8 descendants cleared2024: 19 descendants cleared2023: 17 descendants cleared2017: 10 descendants cleared2025: 24 descendants cleared2018: 9 descendants cleared2026: 24 descendants clearedK992147 · Triple-Fix Spinal Fixation System · Advanced Spine Technology, Inc. · 2000K001668 · Global Spinal Fixation System · D.K.M. Co., Ltd. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 8 descendants5 generations forward: 13 descendants6 generations forward: 9 descendants7 generations forward: 13 descendants8 generations forward: 17 descendants9 generations forward: 30 descendants10 generations forward: 23 descendants11 generations forward: 13 descendants12 generations forward: 15 descendants13 generations forward: 16 descendants14 generations forward: 14 descendants15 generations forward: 1 descendant K001668 · Global Spinal Fixation System · D.K.M. Co., Ltd. · 2000K992147 · Triple-Fix Spinal Fixation System · Advanced Spine Technology, Inc. · 20000+5+10+15
  1. Root · 2 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
  2. 1 generation backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
  3. This deviceK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
  4. Descendant · cites it directly · 178 of its ownK070933 Lowtop Pedicle Screw SystemSanacor · 2007
  5. Descendant · 2 generations on · 177 of its ownK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
  6. Descendant · 3 generations on · 174 of its ownK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
  7. Descendant · 4 generations on · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
  8. Descendant · 5 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled

Showing 5 of 179 descendants. See all descendants

Descendants cleared per year

2007: 22008: 52009: 12010: 42011: 52012: 12013: 72014: 42015: 72016: 72017: 102018: 92019: 42020: 72021: 82022: 142023: 172024: 192025: 242026: 24
2007high 24 (2025) · low 1 (2009)2026

Most influential descendants

Showing 5 of 179 · See all
  • K070933Lowtop Pedicle Screw SystemSanacor · 2007 · cites it directly178descendants
  • K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007 · 2 generations on177descendants
  • K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008 · 3 generations on174descendants
  • K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 4 generations on136descendants
  • K110497Pass LP Spinal SystemMedicrea International · 2011 · 5 generations on133descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K992147Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc.2000—
−1K001668Global Spinal Fixation SystemD.K.M. Co., Ltd.2000—
0 (this device)K031455Conklusion Pedicle Screw SystemSignus Medical, LLC2003—
+1K070933Lowtop Pedicle Screw SystemSanacor2007—
+2K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007—
+3K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008—
+4K100297Pass LP Spinal SystemMedicrea Technologies2010—
+5K110497Pass LP Spinal SystemMedicrea International20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200850
200910
201040
201150
201210
201370
201440
201570
201670
2017100
201890
201940
202070
202180
2022140
2023170
2024190
2025240
2026240
FIG. 1 — Lineage of K031455, 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.

Planning a device in MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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? (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
*K022271Plus Pivot Link Universal System
Summary page 1
…vice is substantially equivalent to the following devices: 0 Plus Pivot Link Universal System (K022271), manufactured by Spinevision, Inc. Global Spinal…
Spine Vision, Inc.2002—
*K001668Global Spinal Fixation SystemD.K.M. Co., Ltd.2000—
*K992147Triple-Fix Spinal Fixation System
Summary page 1
…tion System (KOO1668), manufactured by D.K.M Co., LTD. 0 Triple-Fix Spinal Fixation System (K992 147), manufactured by Advanced Spine Technology, Inc. Device Description : T…
Advanced Spine Technology, Inc.2000—

What descends from it? (179)

See all 179

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070933Lowtop Pedicle Screw SystemSanacor2007178

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 3 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K070933 (Sanacor, 2007) has gone furthest, with 178 descendants of its own.

How does its category compare?

All MNI devices

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

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The Conklusion Pedicle Screw System, including hooks, 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous…

Read the full statement (120 words)

The Conklusion Pedicle Screw System, including hooks, 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Indications for use as stated in the FDA summary.

More from Signus Medical, LLC

6 FDA decisions under this applicant name. See the company

  • K081108Monopoly Pedicle Screw SystemSignus Medical, LLC · 2008
  • K052096Nubic Spinal ImplantSignus Medical, LLC · 2005
  • K031757Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  • K022793Tetris Spinal ImplantSignus Medical, LLC · 2003
  • K020836Rabea Cement RestrictorSignus Medical, LLC · 2002

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K031455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031455: Conklusion Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031455

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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