# K041355: Humeral Staple

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 30, 2004 after 71 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: 3 generations back to K960642 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032687: Ace Nancy Nail, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 1.
- K811002: Ender Pins, Richard'S Medical Equip., Inc. (1981) Summary page 1.
- (no number) Steinman Pin: named in the summary without a submission number

## Indications for use
Humeral staples are intended for fixation of two-part proximal humerus fractures and three-part proximal humerus fractures in conjunction with limited internal fixation such as suture wires. The device is intended for single use.

Source page: https://510kreport.com/device/K041355
Methodology: https://510kreport.com/methodology