# K133525: Locking Compression Bone Plates and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Dean Medical Instrument Co, Ltd.
- Decided: Mar 4, 2014 after 109 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131759: Metallic Locking Compression Bone Plates and Screws System, Tianjin Walkman Biomaterial Co., Ltd. (2013) Summary page 2.

## Indications for use
The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures. including ulna, radius and tibia.

Source page: https://510kreport.com/device/K133525
Methodology: https://510kreport.com/methodology