510(k) Report

510(k) · Cleared

Cleared

TSRH Spinal System

K982990510(k) TraditionalCleared Oct 21, 199856-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. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 21, 1998 after a 56-day review. The FDA summary names no predicate by number. 1 of the 777 devices in its family, counting itself, has a Class I recall. 776 later devices descend from it.

Decided
Oct 21, 1998
Review
56 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

776 later devices descend from it, 8 citing it directly. 1 of the 777 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2007: 2 descendants cleared2001: 1 descendant cleared2003: 1 descendant cleared2002: 3 descendants cleared2011: 11 descendants cleared1999: 1 descendant cleared2009: 4 descendants cleared2015: 48 descendants cleared2004: 1 descendant cleared2008: 3 descendants cleared2010: 4 descendants cleared2012: 19 descendants cleared2000: 1 descendant cleared2016: 45 descendants cleared2014: 39 descendants cleared2017: 53 descendants cleared2013: 38 descendants cleared2018: 57 descendants cleared2019: 43 descendants cleared2024: 61 descendants cleared2022: 53 descendants cleared2021: 48 descendants cleared, 1 with a Class I recall12026: 58 descendants cleared2023: 70 descendants cleared2020: 54 descendants cleared2025: 58 descendants cleared1995200020052010201520202025
  1. This deviceK982990 TSRH Spinal SystemSofamor Danek USA,Inc. · 1998
  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 776 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12001: 12002: 32003: 12004: 12007: 22008: 32009: 42010: 42011: 112012: 192013: 382014: 392015: 482016: 452017: 532018: 572019: 432020: 542021: 482022: 532023: 702024: 612025: 582026: 58
1999high 70 (2023) · low 0 (2005)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 776 · 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)K982990TSRH Spinal SystemSofamor Danek USA,Inc.1998—
+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
199910
200010
200110
200230
200310
200410
200720
200830
200940
201040
2011110
2012190
2013380
2014390
2015480
2016450
2017530
2018570
2019430
2020540
2021481
2022530
2023700
2024610
2025580
2026580
FIG. 1 — Lineage of K982990, 1998–2026Source: 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.

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?

The FDA summary names no predicate by number.

What descends from it? (776)

See all 776

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

NumberDeviceApplicantDecidedDescendants
K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.2007625
K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478
K013440Isobar Spinal SystemScien'Tx USA, Inc.200184
K992738Isobar Spinal SystemEncore Orthopedics, Inc.199963
K013447Isobar Spinal SystemScien'Tx USA, Inc.200238
K110676TSRH Spinal SystemMedtronic Sofamor Danek201136
K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.20021
K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030

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 · 5 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—

What is it indicated for?

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis. (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system…

Read the full statement (271 words)

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis. (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 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/K982990 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982990: 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/K982990

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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