# K213567: Medline UNITE Calcaneal Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Mar 2, 2022 after 113 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: 3 generations back to K022325 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142121: Valor Hindfoot Fusion Nail System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Most influential descendants
- K222665: Medline UNITE® Ankle Fusion Plating System (2023), 0 descendants of its own

## Indications for use
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.

Source page: https://510kreport.com/device/K213567
Methodology: https://510kreport.com/methodology