# K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 11, 2008 after 12 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: 3 generations back to K960642 (1996). 6 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 1.
- K053105: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K143276: Acumed Small Bone IM Nail System (2015), 10 descendants of its own
- K172943: Flex-Thread Fibula Pin System (2017), 4 descendants of its own
- K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System (2021), 3 descendants of its own
- K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System (2021), 1 descendant of its own
- K163488: Flex-Thread Clavicle Pin System (2017), 1 descendant 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 epiphyseal 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 at a point which avoids disruption to the bone growth plate.

Source page: https://510kreport.com/device/K082148
Methodology: https://510kreport.com/methodology