# K161058: Cannulated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Miami Device Solutions, LLC
- Decided: Jul 29, 2016 after 105 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: 8 generations back to K962616 (1996). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141493: Proximal Humerus Plating System, Miami Device Solutions (2015) Summary page 4.
- K041965: Arthrex Humeral Fracture Plates and Screws, Arthrex, Inc. (2004) Summary page 4.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 4.
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series, Zimmer, Inc. (2004) Summary page 4.
- K043227: Periarticular Locking Plates, 2358 Series, Zimmer, Inc. (2004) Summary page 4.
- K043560: Periarticular Locking Plates and Screws, Series 2358 and 2359, Zimmer, Inc. (2005) Summary page 4.
- K050121: Zimmer Periarticular Locking Plate System, Model 2357 & 2359, Zimmer, Inc. (2005) Summary page 4.
- K051098: Periarticular Locking Plates and Screws, Model 2358 Series, Zimmer, Inc. (2005) Summary page 4.

## Most influential descendants
- K173556: Injection Screw (2018), 0 descendants of its own

## Indications for use
The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

Source page: https://510kreport.com/device/K161058
Methodology: https://510kreport.com/methodology