510(k) · Cleared
ClearedTELEGRAPH® EVOLUTION Humeral Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FH Industrie · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Oct 1, 2020 as substantially equivalent to K033510 (Fournitures Hospitalieres Industrie, 2003) and 3 other predicates after a 254-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Oct 1, 2020
- Review
- 254 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K951740 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
- 1 generation backK133376 Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left…Tornier, Inc. · 2013
- This deviceK200127 TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −3 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K082754 | Aequalis Humeral Nail System | Tornier | 2009 | 2 |
| −1 | K133376 | Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right | Tornier, Inc. | 2013 | — |
| 0 (this device) | K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | FH Industrie | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K033510 | Modification to Telegraph Humeral NailSummary page 5…esign, dimension, and materials to the following devices, previously cleared by the FDA: Primary Predicate: • FH Industrie: Modification to TELEGRAPH® HUMERAL NAIL – K033510 Secondary Predicates: • FH Industrie: TELEGRAPH® HUMERAL NAIL– K023241 • FH Industrie: TITANIUM TELEGRAPH® HUMERAL NAIL –… | 2003 |
| * | K023241 | Telegraph Humeral NailSummary page 5…d by the FDA: Primary Predicate: • FH Industrie: Modification to TELEGRAPH® HUMERAL NAIL – K033510 Secondary Predicates: • FH Industrie: TELEGRAPH® HUMERAL NAIL– K023241 • FH Industrie: TITANIUM TELEGRAPH® HUMERAL NAIL – K042332 • Tornier: AEQUALIS HUMERAL NAIL SYSTEM – K133376 Reference Dev… | 2002 |
| * | K042332 | Titanium Telegraph Humeral NailSummary page 5…ion to TELEGRAPH® HUMERAL NAIL – K033510 Secondary Predicates: • FH Industrie: TELEGRAPH® HUMERAL NAIL– K023241 • FH Industrie: TITANIUM TELEGRAPH® HUMERAL NAIL – K042332 • Tornier: AEQUALIS HUMERAL NAIL SYSTEM – K133376 Reference Devices (Biocompatibility predicates): -FH Industrie: CALCANAIL O… | 2004 |
| * | K133376 | Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightSummary page 5…redicates: • FH Industrie: TELEGRAPH® HUMERAL NAIL– K023241 • FH Industrie: TITANIUM TELEGRAPH® HUMERAL NAIL – K042332 • Tornier: AEQUALIS HUMERAL NAIL SYSTEM – K133376 Reference Devices (Biocompatibility predicates): -FH Industrie: CALCANAIL Orthopedic Nail – K150463 -FH Industrie: CALCANAIL Ort… | 2013 |
| † | K150463 | CalcaNail Orthopedic Nail | 2015 |
| † | K150471 | CalcaNail Orthopedic Arthrodesis Nail | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 6.8 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K033510.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 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?
Fracture of the proximal extremity of the humerus.
Fracture of the diaphysis of the humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200127: TELEGRAPH® EVOLUTION Humeral Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200127
Report an extraction error
Are you the manufacturer?
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