In2Bones CoLink™ View Plating System

Vendor/Manufacturer: In2Bones USA, LLC

Product/Product Line: CoLink™ View Plating System

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3030

FDA Regulation Description Classification Name:

Single/multiple component metallic bone fixation appliances and accessories

FDA Classification Product Code: HRS

FDA Classification Product Code Device Name:

Plate, Fixation, Bone

SUBSTANTIALLY EQUIVALENT to the following products:

1. Wright Medical Mini MaxLock Extreme® Plating System

2. In2Bones CoLink™ Plating System

Device Description:

The In2Bones CoLink™ View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) materials.

Indications for Use:

The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.