# K142943: Metallic Locking Bone Plate and Screw

- Pathway: 510(k) (Traditional)
- Applicant: Canwell Medical Co., Ltd.
- Decided: Aug 3, 2015 after 297 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: 6 generations back to K962823 (1996). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073159: Trauson Bone Screw, Models HA 3.5 and 4.5, Trauson (Jiangsu) Medical Instrument Co., Ltd. (2008) Summary page 6.
- K073432: Trauson Bone Plate, Trauson (Jiangsu) Medical Instrument Co., Ltd. (2008) Summary page 6.
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 6.
- K130009: Variax 2 Compression Plating System, Stryker Trauma AG (2013) Summary page 6.

## Indications for use
The metallic locking bone plate and screw are intended for adult patients with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications: - osteotomies, mal-unions, and non-unions; - single, segmental, and comminuted fractures; - normal bone density and osteopenic bone.

Source page: https://510kreport.com/device/K142943
Methodology: https://510kreport.com/methodology