# K181827: Affixus Natural Nail System Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Dec 14, 2018 after 158 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: 6 generations back to K970097 (1997). 18 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033878: Ace Antegrade Retrograde Humeral Nail System, Depuy Ace (2004) Summary page 4.
- K033806: Ace Proximal Humeral Nail System, Depuy Ace (2004) Summary page 4.
- K142281: Zimmer M/DN Intramedullary Fixation System, Zimmer, Inc. (2014) Summary page 4.
- K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 4.

## Most influential descendants
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), 4 descendants of its own
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants of its own
- K200814: Affixus (R) Natural Nail (R) System Humeral Nail (2020), 1 descendant of its own
- K253566: Affixus Retrograde Femoral Nailing System (2026), 0 descendants of its own
- K253749: Affixus® Natural Nail® Proximal Humeral System (2025), 0 descendants of its own

## Indications for use
The AFFIXUS Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as: • Proximal fractures (proximal short and long nails only) • Diaphyseal fractures (proximal long, antegrade/retrograde nails) • Open and closed fractures • Comminuted fractures • Nonunions and malunions • Pathologic fractures.

Source page: https://510kreport.com/device/K181827
Methodology: https://510kreport.com/methodology