# K143002: Metallic Locking Bone Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Dingjian Medical Appliance Co., Ltd.
- Decided: Jun 5, 2015 after 228 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). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130340: Locking Bone Plates and Screws, Weigao Orthopaedic Device Co., Ltd. (2013) Summary page 5.
- K123918: Motionloc Screw for NCB Polyaxial Locking Plate System, Zimmer, Inc. (2013) Summary page 5.

## Most influential descendants
- K190842: Comus Locking Plate systems (2020), 0 descendants of its own

## Indications for use
The Metallic Locking Bone Plate and Screws System are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

Source page: https://510kreport.com/device/K143002
Methodology: https://510kreport.com/methodology