510(k) Report

510(k) · Cleared

Cleared

Modification to TSRH Spinal System

K011029510(k) SpecialCleared Jun 5, 200161-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

Medtronic Sofamor Danek, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jun 5, 2001 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 627 devices in its family, counting itself, has a Class I recall. 626 later devices descend from it.

Decided
Jun 5, 2001
Review
61 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

626 later devices descend from it, 1 citing it directly. 1 of the 627 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2007: 1 descendant cleared2008: 3 descendants cleared2009: 3 descendants cleared2016: 36 descendants cleared2010: 1 descendant cleared2014: 31 descendants cleared2015: 36 descendants cleared2013: 24 descendants cleared2022: 45 descendants cleared2012: 8 descendants cleared2011: 3 descendants cleared2020: 44 descendants cleared2024: 58 descendants cleared2019: 35 descendants cleared2021: 44 descendants cleared, 1 with a Class I recall12023: 62 descendants cleared2025: 55 descendants cleared2017: 42 descendants cleared2018: 42 descendants cleared2026: 53 descendants cleared200020052010201520202025
  1. This deviceK011029 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
  2. Descendant · cites it directly · 625 of its ownK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 614 of its ownK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
  4. Descendant · 3 generations on · 606 of its ownK091797 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
  5. Descendant · 4 generations on · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  6. Descendant · 5 generations on · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled

Showing 5 of 626 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32009: 32010: 12011: 32012: 82013: 242014: 312015: 362016: 362017: 422018: 422019: 352020: 442021: 442022: 452023: 622024: 582025: 552026: 53
2007high 62 (2023) · low 1 (2007)2026

Class I recalls in this family

  • K211616 ExcelsiusHub9 generations on · 2021

Most influential descendants

Showing 5 of 626 · See all
  • K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · cites it directly625descendants
  • K081080TSRH Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on614descendants
  • K091797TSRH Spinal SystemMedtronic Sofamor Danek · 2010 · 3 generations on606descendants
  • K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 4 generations on597descendants
  • K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 5 generations on596descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011029Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2001—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20074
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
200930
201010
201130
201280
2013240
2014310
2015360
2016360
2017420
2018420
2019350
2020440
2021441
2022450
2023620
2024580
2025550
2026530
FIG. 1 — Lineage of K011029, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (626)

See all 626

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

NumberDeviceApplicantDecidedDescendants
K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.2007625

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K072317 (Medtronic Sofamor Danek USA, Inc., 2007) has gone furthest, with 625 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—

More from Medtronic Sofamor Danek, Inc.

125 FDA decisions under this applicant name. See the company

  • K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc. · 2025
  • K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc. · 2025
  • K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
  • P060018/S005Prestige Cervical Disc SystemMedtronic Sofamor Danek, Inc. · 2016
  • P060018/S004PRESTIGE® Cervical DiscMedtronic Sofamor Danek, Inc. · 2016

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/K011029 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011029: Modification to TSRH Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011029

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026