# K220511: Medline UNITE IM Fibula Implant

- Pathway: 510(k) (Special)
- Applicant: Medline Industries, LP
- Decided: Mar 22, 2022 after 28 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: 2 generations back to K082320 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Medline UNITE® IM Fibula Implants 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. Implants are intended for single use only.

Source page: https://510kreport.com/device/K220511
Methodology: https://510kreport.com/methodology