ZhengTian IRENE Cannulated Screw System

Vendor/Manufacturer: Tianjin ZhengTian Medical Instrument Co., Ltd

Product/Product Line: IRENE Cannulated Screw System

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3040

FDA Regulation Description Classification Name:

Smooth or threaded metallic bone fixation fastener

FDA Classification Product Code: HWC

FDA Classification Product Code Device Name:

Screw, Fixation, Bone

SUBSTANTIALLY EQUIVALENT to the following products:

1. OsteoMed Headless Cannulated Screw System

2. Wright Medical DARCO® Headed Cannulated Screws

3. ZhengTian IRENE Locking Compression Plate System

Device Description:

IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).

Indications for Use:

IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.

Acutec Headless Compression Screw:

Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.

Cannulated Screw:

Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.