510(k) · Cleared

Cleared

Telegraph Humeral Nail

K023241510(k) TraditionalCleared Dec 24, 200285-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 24, 2002 as substantially equivalent to K951740 (Acu Med, Inc., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.

Decided: Dec 24, 2002
Review: 85 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951740 (1995). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
This deviceK023241 Telegraph Humeral NailFournitures Hospitalieres Industrie · 2002
Descendant · cites it directly · 9 of its ownK033806 Ace Proximal Humeral Nail SystemDepuy Ace · 2004
Descendant · 2 generations on · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
Descendant · 3 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
Descendant · 4 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
Descendant · 3 generations on · 1 of its ownK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004high 3 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all

K033806Ace Proximal Humeral Nail SystemDepuy Ace · 2004 · cites it directly9descendants
K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · 2 generations on6descendants
K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 3 generations on4descendants
K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 4 generations on2descendants
K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951740	Intramedulary Fixation Rod	Acu Med, Inc.	1995	1
0 (this device)	K023241	Telegraph Humeral Nail	Fournitures Hospitalieres Industrie	2002	—
+1	K033806	Ace Proximal Humeral Nail System	Depuy Ace	2004	—
+2	K181827	Affixus Natural Nail System Humeral Nail	Zimmer GmbH	2018	—
+3	K231114	Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®…	Zimmer Switzerland Manufacturing GmbH	2023	—
+4	K241651	Affixus Tibial and Antegrade Femoral Nailing System	Zimmer, Inc.	2024	17
+3	K200814	Affixus (R) Natural Nail (R) System Humeral Nail	Zimmer GmbH	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2012	1	0
2018	1	0
2020	2	0
2023	1	0
2024	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K023241, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951740	Intramedulary Fixation Rod Summary page 1 …al Nail Classification name: Intramedullary fixation rod Predicate Devices: Polarus Acumed Inc. K 95 1740 FixionTMIntramedullary Nailing System Disc-0-Tech Medical Technologies,…	Acu Med, Inc.	1995	1
*	K010901	Fixion Intramedullary Nailing System (Fixion Imn) Model B Summary page 1 …95 1740 FixionTMIntramedullary Nailing System Disc-0-Tech Medical Technologies, Inc. K 010901 Device description: The TelegraphB Humeral nail is designated to be inserted in the proxima…	Disc-O-Tech Medical Technologies, Ltd.	2001	—

Also cleared against K951740: 4 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K033806	Ace Proximal Humeral Nail System	Depuy Ace	2004	9
K200127	TELEGRAPH® EVOLUTION Humeral Nailing System	FH Industrie	2020	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K033806 (Depuy Ace, 2004) has gone furthest, with 9 descendants of its own.
4 other devices also cite its predicate K951740.

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

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

What is it indicated for?

Telegraph@ Humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023241: 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/K023241

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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