# K163044: ORTHOLOC® 3Di Ankle Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 26, 2017 after 87 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 K082320 (2008). 6 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131093: Ortholoc (R) 3DI Ankle Plating System, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.

## Most influential descendants
- K221558: ALPHALOK Plating System (2022), 2 descendants of its own
- K170313: ARIX Ankle Distal Tibia System (2017), 2 descendants of its own
- K213005: Apollo Ankle Fracture Plating System (2022), 1 descendant of its own
- K212297: Omni Foot and Ankle Plating System (2021), 1 descendant of its own
- K202764: Ortho Solutions Plating System (2020), 1 descendant 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 Malleolus • Pilon Fractures • Distal Tibia Shaft Fractures • Distal Fibula Shaft Fractures • Distal Tibia Periarticular Fractures • Medial Malleolar Avulsion Fractures • Lateral Malleolar Avulsion Fractures ORTHOLOC® 3Di Locking Screws are intended for use with Wright’s ORTHOLOC® 3Di Plating Systems of the same base material. 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. 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/K163044
Methodology: https://510kreport.com/methodology