# K163488: Flex-Thread Clavicle Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Intrafuse, LLC
- Decided: Mar 20, 2017 after 98 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: 4 generations back to K960642 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 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 4.
- K053105: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Synthes (Usa) (2005) Summary page 4.
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 4.
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 4.
- K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension, Synthes (Usa) (2008) Summary page 4.
- K143204: AOS Clavicle Intramedullary Device, Advanced Orthopaedic Solutions, Inc. (2015) Summary page 4.
- K081832: Ensplintcmx Clavicle Pin, Sonoma Orthopedic Products, Inc. (2008) Summary page 5.
- K100112: Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM), Sonoma Orthopedic Products, Inc. (2010) Summary page 5.

## Most influential descendants
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Indications for use
The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Source page: https://510kreport.com/device/K163488
Methodology: https://510kreport.com/methodology