# K222665: Medline UNITE® Ankle Fusion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 25, 2023 after 141 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: 13 generations back to K954385 (1996). 187 ancestors in all.
No later device cites it as a predicate yet.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213567: Medline UNITE Calcaneal Fracture Plating System, Medline Industries, LP (2022) Summary page 4.
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K151235: Medline Foot Plates and Screws, Medline Industries, Inc. (2015) Summary page 5.
- K140397: Paralock Plating System / Tuffnek Screw, Paragon 28 (2014) Summary page 5.

## Indications for use
The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles. The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion 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. The system can be used in both adult and pediatric (adolescent and child) patients. Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws, which span an active growth plate in a pediatric patient, should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.

Source page: https://510kreport.com/device/K222665
Methodology: https://510kreport.com/methodology