# K033878: Ace Antegrade Retrograde Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace
- Decided: Feb 20, 2004 after 67 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: 1 generation back to K934643 (1994). 2 ancestors in all.
10 later devices descend from it; 4 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)
- K934643: Ace Humeral Nail, Ace Orthopedic Manufacturing Co. (1994) Summary page 1.
- K011529: T2 Humeral Nail System, Howmedica Osteonics Corp. (2001) 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® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

Source page: https://510kreport.com/device/K033878
Methodology: https://510kreport.com/methodology