C-Pro Direct and our suppliers take great care to use only materials suitable for Paediatric Orthopaedic Devices. Whilst we cannot guarantee every patient will no adverse reaction to the materials they come in contact with, we do ensure all materials are sourced responsibly and that appropriate independent test data is available. There is no single technical standard defining suitable materials for a Class 1 paediatric medical device, so we have to draw on a range of standards used in a number of regulated industries including food, toys and clothing. The plastics used are generally recognised as “medical or food grade” materials to FDA or other international standards. Fabrics, foams, dyed materials and other sundry items such as screws and metalwork are tested for toxicity in accordance with a broad range of ISO Standards including ROHS (Restriction of Hazardous Substances Directive 2002/95/EC).
Item Description |
Material |
Leg Attachment |
Polyurethane |
Connector Bar |
Co-Polyester |
Heel Piece |
Co-Polyester |
Day Shoe Fitting |
Co-Polyester |
Clip |
POM (Acetal) |
Outer Fabric and Straps |
Night ADMs: 65% Nylon; 35% Polyurethane (non woven microfibre) Day ADMs: Leather |
Leg Attachment Liner |
EVA Foam |
Hook and Loop |
Nylon |
Heel Rubber |
Polyurethane |
Stop Arm |
Stainless Steel |
STJ / TTJ Mechanism Labels |
Vinyl (high-tack permanent adhesive) |
Torsion Springs |
Steel BS 5216 (drawn) |
Spigots |
Stainless Steel |
Internal Bearings |
Steel / PTFE lined |
Thrust Washers |
iglidur® Polymer / A2 Stainless Steel |
Machine Screws |
Stainless Steel |
Thread |
Nylon |
Roller Buckle |
Nickel Plated Iron |
Rivets |
Nickel Plated Iron |
Threaded Inserts |
Brass |