# K173556: Injection Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biedermann Medtech, Inc.
- Decided: Jul 13, 2018 after 238 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: 13 generations back to K960978 (1996). 203 ancestors in all.
No later device cites it as a predicate yet.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142776: Flow-Screw, Flow-Fx, LLC (2015) Summary page 4.
- K151146: N-Force Fixation System, Innovision, Inc. (2015) Summary page 4.
- K161058: Cannulated Screw, Miami Device Solutions, LLC (2016) Summary page 4.
- K132502: Variax 2 System, Stryker Trauma AG (2013) Summary page 4.
- K140769: Variax 2 System, Stryker Trauma AG (2014) Summary page 4.

## Indications for use
The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.

Source page: https://510kreport.com/device/K173556
Methodology: https://510kreport.com/methodology