# K210490: ChM 4.5mm Cortical screws

- Pathway: 510(k) (Traditional)
- Applicant: Chm Sp. Z O.O.
- Decided: Oct 5, 2021 after 228 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: 11 generations back to K962616 (1996). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 5.

## Indications for use
The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Source page: https://510kreport.com/device/K210490
Methodology: https://510kreport.com/methodology