# K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Switzerland Manufacturing GmbH
- Decided: Aug 9, 2023 after 112 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: 7 generations back to K970097 (1997). 29 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091566: Zimmer Natural Nail System Cephalomedullary Nails, Zimmer GmbH (2009) Summary page 5.
- K181827: Affixus Natural Nail System Humeral Nail, Zimmer GmbH (2018) Summary page 5.

## Most influential descendants
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants 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
- K243907: Affixus Tibial Nailing System - 4mm screws (2025), 0 descendants of its own

## Indications for use
The Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) are intramedullary nails intended for temporary internal fixation and stabilization of femoral fractures or osteotomies. Indications for the Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) include: * Compound and simple shaft fractures. * Proximal, metaphyseal and distal shaft fractures. * Segmental fractures. * Comminuted fractures. * Fractures involving osteopenic and osteoporotic bone. * Pathological fractures. * Fractures with bone loss * Pseudoarthrosis, non-union, mal-union and delayed union. * Periprosthetic fractures. * Surgically created defects such as osteotomies. * Intertrochanteric and subtrochanteric fractures. 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/K231114
Methodology: https://510kreport.com/methodology