# K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 23, 2010 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082320 (2008). 2 ancestors in all.
97 later devices descend from it; 9 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091243: Ortholoc Ankle Plating System (Aps), Wrightmedicaltechnologyinc (2009) Summary page 1.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.

## Most influential descendants
- K112772: Ortholoc (TM) Bone Screws (2011), 68 descendants of its own
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K131093: Ortholoc (R) 3DI Ankle Plating System (2013), 26 descendants of its own
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System (2017), 13 descendants of its own

## Recalls of this device
- Nov 8, 2016 · Class II · Z-0563-2020: The firm discovered a lack of adequate documentation confirming sterility on certain products.

## Indications for use
Wright's ORTHOLOCTm 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 * Pilon Fractures * Distal Tibia Shaft Fractures * Distal Fibula Shaft Fractures * Distal Tibia Periarticular Fractures * Medial Malleolar Avuision Fractures * Lateral Malleolar Avusion Fractures The ORTHOLOCTm 3Di locking screws are intended for use with Wright's ORTHOLOCTM 30i Plating Systems of the same base material. ORTHOLOCTm 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/K102429
Methodology: https://510kreport.com/methodology