# K250316: Meduloc Intramedullary Fracture Fixation (IFF) System

- Pathway: 510(k) (Traditional)
- Applicant: Meduloc, LLC
- Decided: Oct 29, 2025 after 267 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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: 8 generations back to K962823 (1996). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131264: Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws, Gebr. Brasseler GmbH & Co. KG (2013) Summary page 5.

## Indications for use
The Meduloc Intramedullary Fracture Fixation (IFF) System is intended for use in the fixation of long bone fractures in both adult and pediatric applications.

Source page: https://510kreport.com/device/K250316
Methodology: https://510kreport.com/methodology