# K221360: Medline UNITE® Medial Malleolus Peg Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Sep 27, 2022 after 139 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: 12 generations back to K954385 (1996). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162829: Medline UNITE® Ankle Fracture Plating System, Medline Industries, Inc. (2016) Summary page 4.
- K132502: Variax 2 System, Stryker Trauma AG (2013) Summary page 5.
- K181820: Medline Unite Mini Plates and Screws, Medline Industries, Inc. (2018) Summary page 5.

## Indications for use
The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, osteotomies, and nonunions of the distal tibia and fibula such as: Medial Malleolar Fractures Lateral Malleolar Fractures Syndesmosis Injuries Bi-Malleolar Fractures Tri-Malleolar Fractures Vertical Shear Fractures of the Medial Malleolus Medial Malleolar Avulsion Fractures Lateral Malleolar Avulsion Fractures In addition, the Medline UNITE® Locking Pegs, when used in conjunction with the Medline UNITE® Mini Plates and Screws, are indicated 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 (adolescent and child) patients.

Source page: https://510kreport.com/device/K221360
Methodology: https://510kreport.com/methodology