# K201319: Medline UNITE Jones Fracture Screw System

- Pathway: 510(k) (Special)
- Applicant: Medline Industires, Inc.
- Decided: Jun 17, 2020 after 30 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: 3 generations back to K053136 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130319: Medline Cannulated Screw, Medline Industries, Inc. (2013) Summary page 4.
- K183026: Wright Jones Fracture System, Wrightmedicaltechnologyinc (2019) Summary page 4.

## Indications for use
The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, non-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.

Source page: https://510kreport.com/device/K201319
Methodology: https://510kreport.com/methodology