# K201259: ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 8, 2021 after 242 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: 4 generations back to K082320 (2008). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System, Wrightmedicaltechnologyinc (2017) Summary page 4.
- K163039: ORTHOLOC® 3Di Small Bones Plating, Wrightmedicaltechnologyinc (2017) Summary page 4.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K192217: NCB Plating System Distal Femur and Proximal Tibia, Zimmer GmbH (2019) Summary page 4.

## Indications for use
The ORTHOLOCTm 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extra-articular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures. ORTHOLOCm 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material. ORTHOLOCm 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/K201259
Methodology: https://510kreport.com/methodology