# K240958: Locking Plates and Screws Systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Hebei Ruihe Medical Devices Co., Ltd.
- Decided: Feb 10, 2025 after 308 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: 10 generations back to K981372 (1998). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150009: Baide, Jiangsu Baide Medical Intrument Co., Ltd. (2015) Summary page 5.
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 5.

## Indications for use
Locking Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws Systems is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

Source page: https://510kreport.com/device/K240958
Methodology: https://510kreport.com/methodology