# K200127: TELEGRAPH® EVOLUTION Humeral Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: FH Industrie
- Decided: Oct 1, 2020 after 254 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951740 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033510: Modification to Telegraph Humeral Nail, Fournitures Hospitalieres Industrie (2003) Summary page 5.
- K023241: Telegraph Humeral Nail, Fournitures Hospitalieres Industrie (2002) Summary page 5.
- K042332: Titanium Telegraph Humeral Nail, Fournitures Hospitalieres Industrie (2004) Summary page 5.
- K133376: Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right, Tornier, Inc. (2013) Summary page 5.

## Indications for use
Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.

Source page: https://510kreport.com/device/K200127
Methodology: https://510kreport.com/methodology