# K181820: Medline Unite Mini Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 1, 2018 after 115 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954385 (1996). 59 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K151235: Medline Foot Plates and Screws, Medline Industries, Inc. (2015) Summary page 4.
- K130319: Medline Cannulated Screw, Medline Industries, Inc. (2013) Summary page 5.

## Most influential descendants
- K250935: TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (2025), 0 descendants of its own
- K221360: Medline UNITE® Medial Malleolus Peg Plate System (2022), 0 descendants of its own

## Indications for use
The Medline Unite® Mini Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include: • Metatarsal or metacarpal fractures and osteotomies • Cuboid fractures • Navicular fractures • Talar neck fractures • Jones and avulsion fractures of the 5th metatarsal • Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies) •Phalanges fractures and osteotomies The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K181820
Methodology: https://510kreport.com/methodology