# K220921: Metal Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Dec 12, 2022 after 257 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: 4 generations back to K792022 (1979). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 4.
- K143146: Nexis osteosynthesis snap-off screws, Novastep (2015) Summary page 4.

## Most influential descendants
- K242348: Locking Screw,CoCrMo (2024), 0 descendants of its own

## Indications for use
Metal Bone Screw 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/K220921
Methodology: https://510kreport.com/methodology