# K191867: ATLAS Plating System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Apr 9, 2020 after 272 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K954385 (1996). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121437: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K190415: ATLAS Plating System, MiRus, LLC (2019) Summary page 4.
- K163039: ORTHOLOC® 3Di Small Bones Plating, Wrightmedicaltechnologyinc (2017) Summary page 4.

## Indications for use
The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.

Source page: https://510kreport.com/device/K191867
Methodology: https://510kreport.com/methodology