TELEGRAPH® EVOLUTION Humeral Nailing System
FDA 510(k) K200127 · FH Industrie
510(k) numberK200127
Submission
- Device name
- TELEGRAPH® EVOLUTION Humeral Nailing System
- Applicant
- FH Industrie
Quimper Finistere, FR - Received
- January 21, 2020
- Decision date
- October 1, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254003 | JARVIS Metaphyseal StemPHX · Special | 01/09/2026SE |
| K253345 | JARVIS Diaphyseal Stem StandardPHX · Special | 10/29/2025SE |
| K252411 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Special | 08/28/2025SE |
| K242253 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Traditional | 11/25/2024SE |
| K232226 | ARROW Off-Centred Humeral InsertPHX · Special | 08/29/2023SE |
| K220758 | e-Ortho Shoulder Software v1.1LLZ · Traditional | 09/30/2022SE |
| K202024 | ARROW Short Stem Humeral SystemPHX · Traditional | 11/30/2021SE |
| K201928 | e-Ortho Shoulder SoftwareLLZ · Traditional | 09/30/2020SE |
Questions and answers
When was TELEGRAPH® EVOLUTION Humeral Nailing System cleared by the FDA?
TELEGRAPH® EVOLUTION Humeral Nailing System (K200127) received a 510(k) decision of Substantially Equivalent on October 1, 2020, 254 days after the submission was received.
What is the product code of K200127?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.