# K033806: Ace Proximal Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace
- Decided: Feb 20, 2004 after 74 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: 2 generations back to K951740 (1995). 3 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951740: Intramedulary Fixation Rod, Acu Med, Inc. (1995) Summary page 1.
- K023241: Telegraph Humeral Nail, Fournitures Hospitalieres Industrie (2002) Summary page 1.

## Most influential descendants
- K181827: Affixus Natural Nail System Humeral Nail (2018), 6 descendants of its own
- 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
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own

## Indications for use
The ACE® Proximal Humeral Nail System is intended for the fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

Source page: https://510kreport.com/device/K033806
Methodology: https://510kreport.com/methodology