# K162380: Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Keyi Medical Device Technology Co., Ltd.
- Decided: May 2, 2017 after 251 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: 8 generations back to K981372 (1998). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101400: Locking Compression Plate, Changzhou Orthmed Medical Instrument Co., Ltd. (2010) Summary page 6.
- K100721: Locking Bone Screw Model HCQ04, HCZ04, Changzhou Orthmar Medical Instrument Co., Ltd. (2010) Summary page 6.
- K130340: Locking Bone Plates and Screws, Weigao Orthopaedic Device Co., Ltd. (2013) Summary page 6.

## Indications for use
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

Source page: https://510kreport.com/device/K162380
Methodology: https://510kreport.com/methodology