# K172213: MECRON Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Merete GmbH
- Decided: Oct 23, 2017 after 91 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 12 generations back to K962616 (1996). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151418: Monster Screw System, Paragon 28 (2015) Summary page 4.

## Indications for use
The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K172213
Methodology: https://510kreport.com/methodology