# K130319: Medline Cannulated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: May 31, 2013 after 112 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: 1 generation back to K082320 (2008). 1 ancestor in all.
12 later devices descend from it; 9 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.

## Most influential descendants
- K181820: Medline Unite Mini Plates and Screws (2018), 2 descendants of its own
- K241359: Medline UNITE® MIS Foot Recon Screw System (2024), 1 descendant of its own
- K234031: Medline UNITE Ancillary Foot Recon Plating System (2024), 1 descendant of its own
- K211612: Medline UNITE REFLEX Dynamic Discs (2021), 1 descendant of its own
- K162829: Medline UNITE® Ankle Fracture Plating System (2016), 1 descendant of its own

## Indications for use
The Medline Cannulated Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Source page: https://510kreport.com/device/K130319
Methodology: https://510kreport.com/methodology