# K182989: AURORA™ Screw System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Dec 18, 2018 after 50 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: 11 generations back to K962616 (1996). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151021: OsteoMed Cannulated Screw System, Osteomed Corp. (2015) Summary page 4.
- K131324: Maxtorque Screw System, Orthohelix Surgical Designs, Inc. (2013) Summary page 4.
- K082574: Maxtorque Mini Cannulated Screw System, Orthohelix Surgical Designs, Inc. (2008) Summary page 4.
- K060428: CSS Cannulated Screw System, Orthohelix Surgical Designs, Inc. (2006) Summary page 4.

## Indications for use
The AURORA™ Screw System is intended to aid in the repair of fractures, fusions and osteotomies of bones and bone fragments.

Source page: https://510kreport.com/device/K182989
Methodology: https://510kreport.com/methodology