510(k) Report

510(k) · Cleared

Recalled · 2012

Intramedulary Fixation Rod

K951740510(k) TraditionalCleared Aug 11, 1995140-day reviewClass II21 CFR 888.3020Recalls 1

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

Acu Med, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Aug 11, 1995 after a 140-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 113 later devices descend from it. It has been recalled once.

Decided
Aug 11, 1995
Review
140 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
0

113 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2002: 1 descendant cleared2014: 5 descendants cleared2003: 1 descendant cleared2013: 9 descendants cleared2020: 8 descendants cleared2005: 1 descendant cleared2012: 5 descendants cleared2008: 1 descendant cleared2010: 2 descendants cleared2009: 2 descendants cleared2022: 6 descendants cleared2018: 3 descendants cleared2025: 10 descendants cleared2017: 7 descendants cleared2026: 14 descendants cleared2006: 1 descendant cleared2023: 7 descendants cleared2011: 6 descendants cleared2015: 5 descendants cleared2019: 5 descendants cleared2024: 6 descendants cleared2007: 1 descendant cleared2016: 3 descendants cleared2021: 3 descendants cleared1995200020052010201520202025
  1. This deviceK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995
  2. Descendant · cites it directly · 100 of its ownK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
  3. Descendant · 2 generations on · 69 of its ownK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
  4. Descendant · 3 generations on · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  6. Descendant · 2 generations on · 22 of its ownK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled

Showing 5 of 113 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 12006: 12007: 12008: 12009: 22010: 22011: 62012: 52013: 92014: 52015: 52016: 32017: 72018: 32019: 52020: 82021: 32022: 62023: 72024: 62025: 102026: 14
2002high 14 (2026) · low 1 (2002)2026

Most influential descendants

Showing 5 of 113 · See all
  • K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003 · cites it directly100descendants
  • K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · 2 generations on69descendants
  • K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · 3 generations on60descendants
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 2 generations on29descendants
  • K082754Aequalis Humeral Nail SystemTornier · 2009 · 2 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951740Intramedulary Fixation RodAcu Med, Inc.1995—
+1K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc.2003—
+2K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.2005—
+3K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.20061
+2K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—
+2K082754Aequalis Humeral Nail SystemTornier20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200510
200610
200710
200810
200920
201020
201160
201250
201390
201450
201550
201630
201770
201830
201950
202080
202130
202260
202370
202460
2025100
2026140
FIG. 1 — Lineage of K951740, 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 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (113)

See all 113

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

NumberDeviceApplicantDecidedDescendants
K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc.2003100
K023241Telegraph Humeral NailFournitures Hospitalieres Industrie200211
K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410
K033806Ace Proximal Humeral Nail SystemDepuy Ace20049
K131636Polarus ConnectAcumed, LLC20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 7, 2012Not classifiedZ-1357-2012Labeling mix-upsThe packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K032722 (Smith & Nephew, Inc., 2003) has gone furthest, with 100 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—

More from Acu Med, Inc.

43 FDA decisions under this applicant name. See the company

  • K021321Wrist Fusion PlateAcu Med, Inc. · 2002
  • K013616Polarus Cap ScrewAcu Med, Inc. · 2001
  • K012655Congruent Bone Plate SystemAcu Med, Inc. · 200116 recalls
  • K992525Acumed Modular Shoulder SystemAcu Med, Inc. · 20001 recall
  • K993657Acumed Suture AnchorAcu Med, Inc. · 2000

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/K951740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951740: Intramedulary Fixation Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951740

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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