# K253749: Affixus® Natural Nail® Proximal Humeral System

- Pathway: 510(k) (Special)
- Applicant: Zimmer Switzerland Manufacturing GmbH
- Decided: Dec 12, 2025 after 17 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: 8 generations back to K970097 (1997). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System, Zimmer Switzerland Manufacturing GmbH (2023) Summary page 5.
- K200814: Affixus (R) Natural Nail (R) System Humeral Nail, Zimmer GmbH (2020) Summary page 5.
- K181827: Affixus Natural Nail System Humeral Nail, Zimmer GmbH (2018) Summary page 5.
- K033806: Ace Proximal Humeral Nail System, Depuy Ace (2004) Summary page 5.
- K033878: Ace Antegrade Retrograde Humeral Nail System, Depuy Ace (2004) Summary page 5.

## Indications for use
The Affixus Natural Nail Humeral Nail System nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies. The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as: * Proximal fractures (proximal short and long nails only) * Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only) * Open and closed fractures * Comminuted fractures * Nonunions and malunions * Pathologic fractures

Source page: https://510kreport.com/device/K253749
Methodology: https://510kreport.com/methodology