510(k) Report

510(k) · Cleared

Cleared

TI-6AL-7NB Urtn

K932330510(k) TraditionalCleared Mar 8, 19961,030-day reviewClass II21 CFR 888.3020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 8, 1996 after a 1,030-day review. The FDA summary names its predicate without a number. 116 later devices descend from it.

Decided
Mar 8, 1996
Review
1,030 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

116 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2014: 6 descendants cleared2005: 1 descendant cleared2018: 9 descendants cleared2008: 2 descendants cleared2009: 4 descendants cleared2020: 9 descendants cleared2026: 9 descendants cleared2001: 1 descendant cleared2003: 3 descendants cleared2007: 2 descendants cleared2002: 2 descendants cleared2011: 3 descendants cleared2010: 2 descendants cleared2004: 4 descendants cleared2013: 5 descendants cleared2017: 7 descendants cleared2024: 5 descendants cleared2025: 9 descendants cleared2015: 2 descendants cleared2019: 7 descendants cleared2012: 2 descendants cleared2023: 7 descendants cleared2016: 3 descendants cleared2022: 7 descendants cleared2006: 1 descendant cleared2021: 3 descendants cleared1995200020052010201520202025
  1. This deviceK932330 TI-6AL-7NB UrtnSynthes (Usa) · 1996
  2. Descendant · cites it directly · 56 of its ownK990717 Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999
  3. Descendant · 2 generations on · 54 of its ownK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
  4. Descendant · 2 generations on · 54 of its ownK013449 Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001
  5. Descendant · cites it directly · 53 of its ownK043270 Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631…Zimmer GmbH · 2005 · Recalled
  6. Descendant · 2 generations on · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002

Showing 5 of 116 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 22003: 32004: 42005: 12006: 12007: 22008: 22009: 42010: 22011: 32012: 22013: 52014: 62015: 22016: 32017: 72018: 92019: 72020: 92021: 32022: 72023: 72024: 52025: 92026: 9
1999high 9 (2018) · low 0 (2000)2026

Most influential descendants

Showing 5 of 116 · See all
  • K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999 · cites it directly56descendants
  • K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · 2 generations on54descendants
  • K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · 2 generations on54descendants
  • K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH · 2005 · cites it directly53descendants
  • K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd. · 2002 · 2 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932330TI-6AL-7NB UrtnSynthes (Usa)1996—
+1K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.1999—
+2K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.20021
+2K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.2001—
+1K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651…Zimmer GmbH20052
+2K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…Disco-O-Tech Medical Technologies, Ltd.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200220
200330
200440
200510
200610
200720
200820
200940
201020
201130
201220
201350
201460
201520
201630
201770
201890
201970
202090
202130
202270
202370
202450
202590
202690
FIG. 1 — Lineage of K932330, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Synthes Unreamed Tibial Nail (stainless steel)
Named without a submission number
—

What descends from it? (116)

See all 116

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

NumberDeviceApplicantDecidedDescendants
K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.199956
K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH200553
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K133166Ins Hilden Tibial ArzztTruemed Group, LLC20141

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, K990717 (Disco-O-Tech Medical Technologies, Ltd., 1999) has gone furthest, with 56 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.

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

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K932330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932330: TI-6AL-7NB Urtn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932330

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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