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TELEGRAPH EVOLUTION Humeral Nailing System

by FH Industrie 510(k)

Active United States

510(k) K200127

Overview

The TELEGRAPH EVOLUTION Humeral Nailing System is a cannulated intramedullary nail designed for internal fixation of proximal and mid-shaft humeral fractures. Classified as an orthopedic fixation device, it stabilizes fractures through interlocking screws and a locking mechanism, facilitating bone alignment and healing. Available in short and long versions, it accommodates varying fracture patterns and anatomical requirements. The system is intended for use in orthopedic surgery to restore function and promote recovery in humeral trauma cases.

This device is supplied sterile and intended for single-use, with components including nails, screws, and instrumentation. It is cleared for use in MRI-safe environments, adhering to established orthopedic fixation protocols. The system is available in multiple diameters and lengths to match patient anatomy, and storage follows manufacturer guidelines to maintain sterility and integrity. The TELEGRAPH EVOLUTION Humeral Nailing System holds an FDA 510(k) clearance under K200127, with regulatory oversight by the Orthopedic Devices Advisory Committee.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200127 Date1 Oct 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the TELEGRAPH® EVOLUTION Humeral Nailing System used for?

    The TELEGRAPH® EVOLUTION Humeral Nailing System is designed for internal fixation of proximal and mid-shaft humeral fractures. It stabilizes fractures through interlocking screws and a locking mechanism, ensuring proper bone alignment to facilitate healing and restore function in trauma cases.

  • How is the TELEGRAPH® EVOLUTION system supplied and intended for use?

    The system is supplied sterile and intended for single-use only. It includes cannulated nails, screws, and instrumentation tailored for orthopedic surgery. The sterile packaging ensures safety for one-time clinical application, adhering to standard orthopedic protocols.

  • Is the TELEGRAPH® EVOLUTION Humeral Nailing System compatible with MRI scans?

    Yes, the system is explicitly designed for use in MRI-safe environments. This compatibility is critical for postoperative imaging without interference, allowing continuous monitoring of bone healing and alignment.

  • What variations in size and length are available for the TELEGRAPH® EVOLUTION system?

    The system offers short and long nail versions to accommodate different fracture patterns and anatomical requirements. Additionally, multiple diameters and lengths are available to match individual patient anatomy, ensuring optimal fit and stability during fixation.

  • How should the TELEGRAPH® EVOLUTION Humeral Nailing System be stored to maintain sterility?

    Storage must follow the manufacturer’s guidelines to preserve sterility and integrity. This typically involves keeping the system in its original packaging, away from moisture, extreme temperatures, and direct sunlight, until ready for use in a sterile surgical environment.