# K162829: Medline UNITE® Ankle Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 9, 2016 after 63 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). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 4.
- K082072: Synthes (Usa) 3.5MM LCP Hook Plate, Synthes (Usa) (2008) Summary page 4.
- K091243: Ortholoc Ankle Plating System (Aps), Wrightmedicaltechnologyinc (2009) Summary page 4.
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K151235: Medline Foot Plates and Screws, Medline Industries, Inc. (2015) Summary page 5.
- K130319: Medline Cannulated Screw, Medline Industries, Inc. (2013) Summary page 5.

## Most influential descendants
- K221360: Medline UNITE® Medial Malleolus Peg Plate System (2022), 0 descendants of its own

## Indications for use
Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, osteotomies and nonunions of the distal tibia and fibula such as: • Lateral Malleolar Fractures • Syndesmosis Injuries • Medial Malleolar Fractures • Bi-Malleolar Fractures • Tri-Malleolar Fractures • Posterior Malleolar Fractures • Distal Anterior Tibia Fractures • Vertical Shear Fractures of the Medial Malleolous • Pilon Fractures • Distal Tibia Shaft Fractures • Distal Fibula Shaft Fractures • Distal Tibia Periarticular Fractures • Medial Malleolar Avulsion Fractures • Lateral Malleolar Avulsion Fractures The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture 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/K162829
Methodology: https://510kreport.com/methodology