# K190842: Comus Locking Plate systems

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Trauhui Medical Instrument Co., Ltd.
- Decided: Feb 3, 2020 after 308 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: 9 generations back to K981372 (1998). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143002: Metallic Locking Bone Plate and Screw System, Changzhou Dingjian Medical Appliance Co., Ltd. (2015) Summary page 5.

## Indications for use
Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.

Source page: https://510kreport.com/device/K190842
Methodology: https://510kreport.com/methodology