# K163037: Intra medullary endo-transilluminating device (iMET device)

- Pathway: 510(k) (Traditional)
- Applicant: WeMED Bio-Tech, Inc.
- Decided: Feb 17, 2017 after 109 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K962330 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070021: Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0, Jg Medical Products, LLC (2007) Summary page 5.

## Indications for use
The Intra medullary endo-Transilluminating device (iMET), together with all its components, is for use in performing interlocking screw holes positioning during intra-medullary nailing procedure. It is designed to assist surgeons who need to fix fractured long bone , such as tibia, femur, or humerus by providing illumination intramedullary for rapid and precise screw holes positioning without using C-arms thus no extra radiation dosage was absorbed.

Source page: https://510kreport.com/device/K163037
Methodology: https://510kreport.com/methodology