510(k) Report

510(k) · Cleared

Cleared

Trigen Straight Humeral Nail System

K032722510(k) SpecialCleared Oct 1, 200328-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

Smith & Nephew, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Oct 1, 2003 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1995. 100 later devices descend from it.

Decided
Oct 1, 2003
Review
28 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K951740 (1995). 3 ancestors in all. 100 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors2005: 1 descendant cleared2012: 4 descendants cleared2008: 1 descendant cleared2010: 2 descendants cleared2014: 5 descendants cleared2009: 2 descendants cleared2022: 6 descendants cleared2020: 7 descendants cleared2006: 1 descendant cleared2023: 6 descendants cleared2018: 2 descendants cleared2013: 8 descendants cleared2011: 6 descendants cleared2015: 5 descendants cleared2017: 7 descendants cleared2026: 13 descendants cleared2024: 5 descendants cleared2007: 1 descendant cleared2025: 7 descendants cleared2016: 3 descendants cleared2019: 5 descendants cleared2021: 3 descendants clearedK951740 · Intramedulary Fixation Rod · Acu Med, Inc. · 1995 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 16 descendants3 generations forward: 33 descendants4 generations forward: 18 descendants5 generations forward: 8 descendants6 generations forward: 9 descendants7 generations forward: 6 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K951740 · Intramedulary Fixation Rod · Acu Med, Inc. · 1995 · recalled0+5
  1. Root · 1 generation backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
  2. This deviceK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
  3. Descendant · cites it directly · 69 of its ownK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
  4. Descendant · 2 generations on · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
  5. Descendant · cites it directly · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  6. Descendant · cites it directly · 22 of its ownK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
  7. Descendant · 3 generations on · 18 of its ownK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 12009: 22010: 22011: 62012: 42013: 82014: 52015: 52016: 32017: 72018: 22019: 52020: 72021: 32022: 62023: 62024: 52025: 72026: 13
2005high 13 (2026) · low 1 (2005)2026

Most influential descendants

Showing 5 of 100 · See all
  • K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · cites it directly69descendants
  • K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · 2 generations on60descendants
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · cites it directly29descendants
  • K082754Aequalis Humeral Nail SystemTornier · 2009 · cites it directly22descendants
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · 3 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K951740Intramedulary Fixation RodAcu Med, Inc.19951
0 (this device)K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc.2003—
+1K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.2005—
+2K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.20061
+1K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—
+1K082754Aequalis Humeral Nail SystemTornier20092
+3K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200810
200920
201020
201160
201240
201380
201450
201550
201630
201770
201820
201950
202070
202130
202260
202360
202450
202570
2026130
FIG. 1 — Lineage of K032722, 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), 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? (3)

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
*K981529Titanium Intramedullary Nail, Titanium Locking Screw
Summary page 1
…ies in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K98 1529), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K95 1740). *+*'-J {+ $&…
Smith & Nephew, Inc.19982
*K983942Intramedullary Nail System, Locking Screw, Nail Cap
Summary page 1
…principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K98 1529), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K95 1740). *+*'-J {+ $& DEPARTMENT OF HEALTH & HUMAN SERVICES…
Smith & Nephew, Inc.1998—
*K951740Intramedulary Fixation Rod
Summary page 1
…to the following predicate devices - Smith & Nephew's Titanium Nail System (K98 1529), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K95 1740). *+*'-J {+ $& DEPARTMENT OF HEALTH & HUMAN SERVICES Pub…
Acu Med, Inc.19951

Also cleared against K981529: 15 other devices →

What descends from it? (100)

See all 100

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

NumberDeviceApplicantDecidedDescendants
K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569
K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029
K082754Aequalis Humeral Nail SystemTornier200922
K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410
K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083
K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.20220
K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.20120

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?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K051557 (Smith & Nephew, Inc., 2005) has gone furthest, with 69 descendants of its own.
  • 15 other devices also cite its predicate K981529.

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?

The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K981529

15 other devices cite the same predicate.

  • K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023
  • K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 20224 recalls
  • K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 20121 recall
  • K111025Trigen Low Profile Bone ScrewSmith & Nephew, Inc. · 20111 recall
  • K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp. · 2010
  • K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 20101 recall

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K032722 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032722: Trigen Straight Humeral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032722

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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