510(k) Report

510(k) · Cleared

Cleared

Modification to TSRH Spinal System

K050282510(k) SpecialCleared Feb 18, 200511-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 · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Feb 18, 2005 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 788 devices in its family, counting itself, has a Class I recall. 787 later devices descend from it.

Decided
Feb 18, 2005
Review
11 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
0

787 later devices descend from it, 2 citing it directly. 1 of the 788 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2007: 2 descendants cleared2005: 1 descendant cleared2010: 8 descendants cleared2009: 6 descendants cleared2012: 21 descendants cleared2008: 3 descendants cleared2016: 46 descendants cleared2014: 42 descendants cleared2015: 49 descendants cleared2011: 11 descendants cleared2022: 53 descendants cleared2013: 39 descendants cleared2018: 57 descendants cleared2020: 55 descendants cleared2017: 53 descendants cleared2025: 58 descendants cleared2019: 43 descendants cleared2023: 72 descendants cleared2024: 61 descendants cleared2021: 48 descendants cleared, 1 with a Class I recall12026: 59 descendants cleared20052010201520202025
  1. This deviceK050282 Modification to TSRH Spinal SystemMedtronic Sofamor Danek · 2005
  2. Descendant · cites it directly · 786 of its ownK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
  3. Descendant · 2 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  4. Descendant · cites it directly · 625 of its ownK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
  5. Descendant · 2 generations on · 614 of its ownK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
  6. Descendant · 2 generations on · 606 of its ownK091797 TSRH Spinal SystemMedtronic Sofamor Danek · 2010

Showing 5 of 787 descendants. See all descendants

Descendants cleared per year

2005: 12007: 22008: 32009: 62010: 82011: 112012: 212013: 392014: 422015: 492016: 462017: 532018: 572019: 432020: 552021: 482022: 532023: 722024: 612025: 582026: 59
2005high 72 (2023) · low 0 (2006)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 787 · See all
  • K052054TSRH Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly786descendants
  • K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 2 generations on656descendants
  • 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 · 2 generations on606descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050282Modification to TSRH Spinal SystemMedtronic Sofamor Danek2005—
+1K052054TSRH Spinal SystemMedtronic Sofamor Danek2005—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20074
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008—
+2K091797TSRH Spinal SystemMedtronic Sofamor Danek2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200720
200830
200960
201080
2011110
2012210
2013390
2014420
2015490
2016460
2017530
2018570
2019430
2020550
2021481
2022530
2023720
2024610
2025580
2026590
FIG. 1 — Lineage of K050282, 2005–2026Source: 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.

Top candidate predicates for a new NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (787)

See all 787

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

NumberDeviceApplicantDecidedDescendants
K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K052054 (Medtronic Sofamor Danek, 2005) has gone furthest, with 786 descendants of its own.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

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  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K050282 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050282: Modification to TSRH Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050282

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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