510(k) Report

510(k) · Cleared

Cleared

Titanium TSRH (R) Spinal System (Screws)

K946348510(k) TraditionalCleared Aug 7, 1995220-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

Sofamor Danek USA,Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Aug 7, 1995 after a 220-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Aug 7, 1995
Review
220 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2021: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK946348 Titanium TSRH (R) Spinal System (Screws)Sofamor Danek USA,Inc. · 1995
  2. Descendant · cites it directly · 10 of its ownK131980 Sequoia Pedicle Screw System Including Speedlink II Transverse…Zimmer Spine, Inc. · 2013
  3. Descendant · 2 generations on · 8 of its ownK203507 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021
  4. Descendant · 3 generations on · 5 of its ownK230116 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023
  5. Descendant · 4 generations on · 4 of its ownK240539 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
  6. Descendant · 5 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2013: 22015: 12021: 12022: 12023: 12024: 22025: 22026: 2
2013high 2 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 12 · See all
  • K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc. · 2013 · cites it directly10descendants
  • K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021 · 2 generations on8descendants
  • K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023 · 3 generations on5descendants
  • K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024 · 4 generations on4descendants
  • K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K946348Titanium TSRH (R) Spinal System (Screws)Sofamor Danek USA,Inc.1995—
+1K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.2013—
+2K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2021—
+3K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)2023—
+4K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)2024—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201510
202110
202210
202310
202420
202520
202620
FIG. 1 — Lineage of K946348, 1995–2026Source: 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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.201310
K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130

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, K131980 (Zimmer Spine, Inc., 2013) has gone furthest, with 10 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 Sofamor Danek USA,Inc.

41 FDA decisions under this applicant name. See the company

  • K991031Colorado II Spinal SystemSofamor Danek USA,Inc. · 20001 recall
  • K984360Colorado II Spinal SystemSofamor Danek USA,Inc. · 2000
  • K992928CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
  • K991036Danek Plate and Screw SystemSofamor Danek USA,Inc. · 1999
  • K991198Dyna-Lok Plus Spinal SystemSofamor Danek USA,Inc. · 1999

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/K946348 · printed Nov 5, 2026

Cite this page

510(k) Report. “K946348: Titanium TSRH (R) Spinal System (Screws).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946348

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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