# K121425: Ortholoc 3DI Ankle Fusion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 1, 2012 after 140 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 K010612 (2001). 96 ancestors in all.
53 later devices descend from it; 10 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates, Smith & Nephew, Inc. (2011)
- K100176: Ascension Ankle Fusion Plate System, Ascension Orthopedics, Inc. (2010) Summary page 1.
- K090139: Ankle Arthrodesis Plate System, Tornier, Inc. (2009) Summary page 1.
- K073375: Newdeal Tibiaxys System, Newdeal Sas (2008) Summary page 1.
- K060473: TTC Plate, New Deal, S.A. (2006) Summary page 1.
- K061940: Synthes LCP Ankle Arthrodesis Plates, Synthes (Usa) (2006) Summary page 1.
- K112772: Ortholoc (TM) Bone Screws, Wrightmedicaltechnologyinc (2011)

## Most influential descendants
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (2017), 12 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K170693: Phantom Small Bone Intramedullary Nail System (2017), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own

## Indications for use
Wright's ORTHOLOC 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus. ORTHOLOC Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K121425
Methodology: https://510kreport.com/methodology