510(k) Report

510(k) · Cleared

Cleared

Modification to Telegraph Humeral Nail

K033510510(k) SpecialCleared Dec 3, 200327-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

Fournitures Hospitalieres Industrie · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 3, 2003 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.

Decided
Dec 3, 2003
Review
27 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

25 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2020: 3 descendants cleared2009: 1 descendant cleared2013: 1 descendant cleared2011: 1 descendant cleared2026: 3 descendants cleared2017: 3 descendants cleared2012: 1 descendant cleared2023: 2 descendants cleared2014: 2 descendants cleared2025: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2019: 2 descendants cleared200020052010201520202025
  1. This deviceK033510 Modification to Telegraph Humeral NailFournitures Hospitalieres Industrie · 2003
  2. Descendant · cites it directly · 24 of its ownK042332 Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie · 2004
  3. Descendant · 2 generations on · 22 of its ownK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
  4. Descendant · 3 generations on · 17 of its ownK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · Recalled
  5. Descendant · 4 generations on · 15 of its ownK120807 Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012
  6. Descendant · 5 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12009: 12011: 12012: 12013: 12014: 22017: 32019: 22020: 32021: 12023: 22024: 12025: 22026: 3
2004high 3 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 25 · See all
  • K042332Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie · 2004 · cites it directly24descendants
  • K082754Aequalis Humeral Nail SystemTornier · 2009 · 2 generations on22descendants
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · 3 generations on17descendants
  • K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012 · 4 generations on15descendants
  • K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 5 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033510Modification to Telegraph Humeral NailFournitures Hospitalieres Industrie2003—
+1K042332Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie2004—
+2K082754Aequalis Humeral Nail SystemTornier20092
+3K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)20112
+4K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC2012—
+5K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…I.T.S. GmbH2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200910
201110
201210
201310
201420
201730
201920
202030
202110
202320
202410
202520
202630
FIG. 1 — Lineage of K033510, 2003–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K042332Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie200424
K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie20200
K052058Modification to: Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie20050

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, K042332 (Fournitures Hospitalieres Industrie, 2004) has gone furthest, with 24 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?

The Telegraph® Humeral Nail is indicated for proximal and/or diaphyseal fractures of the humerus.

Indications for use as stated in the FDA 510(k) statement.

More from Fournitures Hospitalieres Industrie

24 FDA decisions under this applicant name. See the company

  • K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  • K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie · 2017
  • K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  • K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017

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/K033510 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033510: Modification to Telegraph Humeral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033510

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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