# K131093: Ortholoc (R) 3DI Ankle Plating System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 21, 2013 after 33 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: 2 generations back to K082320 (2008). 3 ancestors in all.
26 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Most influential descendants
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System (2017), 13 descendants of its own
- K143061: Activ Ankle Locking Plating System (2015), 8 descendants of its own
- K152289: Alians Elbow Locking Plating System (2016), 6 descendants of its own
- K173641: Activ Ankle (2018), 3 descendants of its own
- K221558: ALPHALOK Plating System (2022), 2 descendants of its own

## Indications for use
Wright's ORTHOLOC®)3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions 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 * Piton Fractures * Distal Tibia Shaft Fractures * Distal Fibula Shaft Fractures * Distal Tibia Periarticular Fractures * Medial Malleolar Avulsion Fractures * Lateral Malleolar Axusian Fractures ORTHOLOC® 3Di Locking Screws: The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material. ORTHOLOC® Bone Screws: ORTHOLOC® Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device. Washer Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Source page: https://510kreport.com/device/K131093
Methodology: https://510kreport.com/methodology