# K211944: Medline UNITE® Digital Fusion Screw System

- Pathway: 510(k) (Special)
- Applicant: Medline Industries, Inc.
- Decided: Jul 22, 2021 after 29 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 K960385 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 4.

## Indications for use
The Medline UNITE® Digital Fusion 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 including corrective procedures for hammertoe, mallet toe, and claw toe deformities. Screws are intended for single use only.

Source page: https://510kreport.com/device/K211944
Methodology: https://510kreport.com/methodology