# K971783: Synthes Elastic Intramedullary Nail (Ein) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 18, 1997 after 65 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: 1 generation back to K960642 (1996). 1 ancestor in all.
49 later devices descend from it; 13 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960642: Nancy Nail, Landos, Inc. (1996) Summary page 1.

## Most influential descendants
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System (2008), 29 descendants of its own
- K032687: Ace Nancy Nail (2003), 17 descendants of its own
- K020885: Fassire-Duval Telescopic IM System (2003), 15 descendants of its own
- K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension (2008), 14 descendants of its own
- K041393: Fassier-Duval Telscopic IM System (2004), 14 descendants of its own

## Indications for use
The Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

Source page: https://510kreport.com/device/K971783
Methodology: https://510kreport.com/methodology