# K130340: Locking Bone Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Weigao Orthopaedic Device Co., Ltd.
- Decided: Apr 5, 2013 after 53 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: 7 generations back to K981372 (1998). 16 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 24 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 2.
- K100721: Locking Bone Screw Model HCQ04, HCZ04, Changzhou Orthmar Medical Instrument Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K133840: Kangli Locking Plate System (2014), 2 descendants of its own
- K143002: Metallic Locking Bone Plate and Screw System (2015), 1 descendant of its own
- K150009: Baide (2015), 1 descendant of its own
- K240958: Locking Plates and Screws Systems (2025), 0 descendants of its own
- K190842: Comus Locking Plate systems (2020), 0 descendants of its own

## Indications for use
Locking Bone Plates and Screws 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/K130340
Methodology: https://510kreport.com/methodology