# K242348: Locking Screw,CoCrMo

- Pathway: 510(k) (Abbreviated)
- Applicant: Double Medical Technology, Inc.
- Decided: Dec 4, 2024 after 118 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K954385 (1996). 191 ancestors in all.
No later device cites it as a predicate yet.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220921: Metal Bone Screw, Double Medical Technology, Inc. (2022) Summary page 5.
- K221088: Anatomic Bone Plate, Double Medical Technology, Inc. (2023) Summary page 5.
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 5.
- K221150: Advanced Bone Plate, Double Medical Technology, Inc. (2023) Summary page 5.

## Indications for use
Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Source page: https://510kreport.com/device/K242348
Methodology: https://510kreport.com/methodology