510(k) Report

510(k) · Cleared

Cleared

TSRH Spinal System

K010720510(k) SpecialCleared Apr 11, 200130-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. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Apr 11, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 249 later devices descend from it.

Decided
Apr 11, 2001
Review
30 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

249 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 9 descendants cleared2010: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2018: 17 descendants cleared2022: 24 descendants cleared2012: 2 descendants cleared2013: 10 descendants cleared2017: 14 descendants cleared2014: 7 descendants cleared2016: 10 descendants cleared2015: 12 descendants cleared2024: 29 descendants cleared2026: 30 descendants cleared2020: 11 descendants cleared2023: 26 descendants cleared2025: 30 descendants cleared2021: 13 descendants cleared200020052010201520202025
  1. This deviceK010720 TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
  2. Descendant · cites it directly · 244 of its ownK103049 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
  3. Descendant · 2 generations on · 242 of its ownK111942 TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011
  4. Descendant · 3 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
  5. Descendant · 3 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
  6. Descendant · 4 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015

Showing 5 of 249 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12008: 12010: 12011: 12012: 22013: 102014: 72015: 122016: 102017: 142018: 172019: 92020: 112021: 132022: 242023: 262024: 292025: 302026: 30
2002high 30 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 249 · See all
  • K103049TSRH Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly244descendants
  • K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on242descendants
  • K123138Pass LP Spinal SystemMedicrea International · 2013 · 3 generations on132descendants
  • K121630Range Spinal SystemK2m, Inc. · 2012 · 3 generations on127descendants
  • K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 4 generations on84descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010720TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2001—
+1K103049TSRH Spinal SystemMedtronic Sofamor Danek2010—
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011—
+3K123138Pass LP Spinal SystemMedicrea International2013—
+3K121630Range Spinal SystemK2m, Inc.2012—
+4K142798PASS LP Spinal SystemMedicrea International SA2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200810
201010
201110
201220
2013100
201470
2015120
2016100
2017140
2018170
201990
2020110
2021130
2022240
2023260
2024290
2025300
2026300
FIG. 1 — Lineage of K010720, 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.

Planning a device in MNH? 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?

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

What descends from it? (249)

See all 249

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

NumberDeviceApplicantDecidedDescendants
K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244
K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc.20023
K190376PASS LP Spinal SystemMedicrea International SA20191

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?

  • Of its descendants, K103049 (Medtronic Sofamor Danek, 2010) has gone furthest, with 244 descendants of its own.

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—

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 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/K010720 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010720: 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/K010720

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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