# K170782: Medline UNITE® Snap-Off Screws

- Pathway: 510(k) (Special)
- Applicant: Medline Industries, Inc.
- Decided: Aug 18, 2017 after 156 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 K043583 (2005). 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.
- K133713: Charlotte (TM) Snap-Off Screw, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Indications for use
The Medline UNITE® Snap-Off 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/K170782
Methodology: https://510kreport.com/methodology