# K032687: Ace Nancy Nail

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 6, 2003 after 38 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K960642 (1996). 2 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K081097: Orthopediatrics Pediflex Flexible Nail System (2008), 11 descendants of its own
- K082375: Orthopediatrics Pediflex Flexible Nail System (2008), 10 descendants of its own
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), 6 descendants of its own
- K192710: The Simple Locking Intramedullary (Slim) System (2020), 5 descendants of its own
- K231266: Pediatric Nailing Platform  Tibia (2023), 2 descendants of its own

## Indications for use
The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of age and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.

Source page: https://510kreport.com/device/K032687
Methodology: https://510kreport.com/methodology