# K151057: WASTON Metallic Bone Plate and Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Waston Medical Appliance Co., Ltd.
- Decided: Aug 10, 2015 after 112 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: 11 generations back to K962616 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 7.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 7.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 7.

## Indications for use
WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.

Source page: https://510kreport.com/device/K151057
Methodology: https://510kreport.com/methodology