Product Overview

The document provides technical information about the Cementless SYMBOL® Stems without collar, manufactured by DEDIENNE SANTÉ in Mauguio, France. These orthopedic implants are designed for femoral stem applications in hip replacements.

Material Specifications

• Stem Material: TA6V Titanium alloy compliant with ISO 5832-3.
• Coating: Hydroxyapatite coating conforming to ISO 13779-2, enhancing osseointegration.
• Femoral Heads: Available in Cobalt-Chromium (Co-Cr) alloy per ISO 5832-12 and Delta Ceramic per ISO 6474-2.

Product Variants and Sizes

The stems are available in multiple sizes ranging from size 1 to size 10, with specific product codes assigned to each size. The femoral heads come in various diameters (22.2mm, 28mm, 32mm, 36mm) and neck lengths (short, medium, long) with corresponding neck offsets:

• 22.2mm heads: Short Neck (-2.5mm), Medium Neck (0mm), Long Neck (+2.5mm)
• 28mm heads: Short Neck (-3.5mm), Medium Neck (0mm), Long Neck (+3.5mm)
• 32mm heads: Short Neck (-3.5mm), Medium Neck (0mm), Long Neck (+3.5mm)
• 36mm heads: Short Neck (-4mm), Medium Neck (0mm), Long Neck (+4mm)

Design Features

• The stems are collarless, which may influence surgical technique and implant stability.
• Femoral heads are designed with neck-shaft angles of 130° and 120°, allowing for anatomical customization.

Standards and Certifications

• Manufactured under ISO 13485 quality management system for medical devices.
• Compliance with relevant ISO standards for materials and coatings ensures biocompatibility and performance.

Manufacturer Contact Information

DEDIENNE SANTÉ
Le Mas des Cavaliers, 217 Rue Nungesser, 34130 Mauguio, France
Email: [email protected]
Phone: +33 (0)4 66 28 06 85

Summary of Critical Information

• Implants are titanium alloy stems with hydroxyapatite coating for cementless fixation.
• Multiple sizes and neck length options accommodate patient anatomy.
• Femoral heads available in metal and ceramic materials with various diameters and neck-shaft angles.
• Manufactured in compliance with international standards ensuring quality and safety.