# K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 7, 2004 after 59 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
No predicates in its family tree.
36 later devices descend from it; 9 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Elastic Intramedullary Nail (FIN) System: named in the summary without a submission number
- (no number) Depuy Ace Nancy Nail: named in the summary without a submission number

## Most influential descendants
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System (2008), 29 descendants of its own
- K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension (2008), 14 descendants of its own
- K143276: Acumed Small Bone IM Nail System (2015), 10 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

## Indications for use
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the 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-stature patients. This system is also intended to treat metaphyseal and epiphyscal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted tf point which avoids disruption to the bone growth plate.

Source page: https://510kreport.com/device/K042135
Methodology: https://510kreport.com/methodology