510(k) Report

510(k) · Cleared

Cleared

Pillar Pedicle Screw System

K071743510(k) TraditionalCleared Jul 6, 20079-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

The 4th Column, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jul 6, 2007 as substantially equivalent to K982511 (Depuy, Inc., 1998) and 2 other predicates after a 9-day review. Its family tree reaches back 3 generations to 1995.

Decided
Jul 6, 2007
Review
9 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K951116 (1995). 11 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1996: 3 other ancestors1997: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestorK951116 · Acromed Pedicle Screw · Acromed Corp. · 1995K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 19981990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K951116 · Acromed Pedicle Screw · Acromed Corp. · 19950
  1. Root · 3 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 2 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. 1 generation backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. This deviceK071743 Pillar Pedicle Screw SystemThe 4th Column, LLC · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K951116Acromed Pedicle ScrewAcromed Corp.1995—
−2K963639Acromed Pedicle ScrewAcromed Corp.1996—
−1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
0 (this device)K071743Pillar Pedicle Screw SystemThe 4th Column, LLC2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199630
199710
199810
FIG. 1 — Lineage of K071743, 1995–2007Source: 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK001585FDA’s K001585 is Biocurve Soft (Methafilcon a) Spherical and Toric Soft Contact Lens for Daily…
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
American Biocurve, Inc.2001—
*K982511Depuy Motech Moss Miami Spinal Systems
Summary page 2
…ations and dcsimn principles to the following preamendment devices: the OPTIMAT M Spinal System (K0 1585) from U&i Corporation, America and the Moss Miami Spinal System (K98251 1, K983583. K955348) from DePuy, Inc. DEPARTMENT OF HEALTH & HUMAN SERVICES…
Depuy, Inc.1998—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 2
…dcsimn principles to the following preamendment devices: the OPTIMAT M Spinal System (K0 1585) from U&i Corporation, America and the Moss Miami Spinal System (K98251 1, K983583. K955348) from DePuy, Inc. DEPARTMENT OF HEALTH & HUMAN SERVICES Pub…
Depuy, Inc.1998—
*K955348Titanium Moss Miami Spinal System
Summary page 2
…rinciples to the following preamendment devices: the OPTIMAT M Spinal System (K0 1585) from U&i Corporation, America and the Moss Miami Spinal System (K98251 1, K983583. K955348) from DePuy, Inc. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt…
Depuy, Inc.1996—

Also cleared against K982511: 4 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 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • None of the 11 ancestors has a recall.
  • 4 other devices also cite its predicate K982511.

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. 2007, this device’s year, is highlighted.

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 Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. The Pillar Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature…

Read the full statement (116 words)

The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The Pillar Pedicle Screw System also 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K982511

4 other devices cite the same predicate.

  • K160926F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  • K120291OP Spine SystemOrthoPediatrics Corp. · 2012
  • K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC · 2007
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003

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/K071743 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071743: Pillar 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/K071743

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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