Description: Medical-grade, biocompatible PEEK polymer materials Our wide range of biocompatible polymer materials and compounds are each designed to meet the specific and rigorous demands of implantable medical devices. PEEK materials are tailored to offer superior performance in a variety of applications including spine, orthopedic, trauma, dental and specialty devices. Innovative PEEK materials and our in-depth manufacturing knowledge combined with application expertise supports medical device companies to bring leading edge devices to market and open up new areas of growth. BIOMATERIAL PROPERTY Properties Information Property Reference Standard Test Method Unit Specification Result Physical Properties Glass Transition ASTM F2026 ASTM D3418 °C 125-165 147 Temperature, Tg Melt Temperature, Tm ASTM F2026 ASTM D3418 °C 320-360 338 Recrystallization ASTM F2026 ASTM D3418 °C 260-320 289 Temperature, Tc Viscosity ASTM F2026 ISO 11443 Pa·s 400-480 437 Infrared Spectrum ASTM F2026 ASTM F1579 / See Appendix X1 See Appendix X2 Density ASTM F2026 ASTM D1505 kg/m3 1280-1320 1294 Chemical Properties Total Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), max ASTM F2026 US Pharmacopeia, ppm BIOMATERIAL PROPERTY

Medical-grade, Biocompatible PEEK Polymer Materials PEEK Catheter Tubing is a thermoplastic polymer that can be extruded into catheter tubing with desirable properties such as high tensile strength, buckling resistance, good pushability and radiopacity. BIOMATERIAL PROPERTY Key Features of PEEK Tubing: • Ultra hard material • Very good chemical resistance • Stable at temperatures up to 228°C • Excellent abrasion resistance • Flame retardant (UL94 V-0) • Very tight dimensional tolerances PEEK Tubing: • In coils, on spools or straight lengths with clean, square cuts • Translucent or Opaque • Wall thickness varying along length (Bumped tubing) • Coloured PEEK tubing • Multi-Layer PEEK tubing • Reinforced PEEK tubing (Stainless Steel Wires) • Shaped tubing Properties Information Property Reference Standard Test Method Unit Specification Result Physical Properties Glass Transition ASTM F2026 ASTM D3418 °C 125-165 147 Temperature, Tg Melt Temperature, Tm ASTM F2026 ASTM D3418 °C 320-360 338 Recrystallization ASTM F2026 ASTM D3418 °C 260-320 289 Temperature, Tc Viscosity ASTM F2026 ISO 11443 Pa·s 400-480 437 Infrared Spectrum ASTM F2026 ASTM F1579 / See Appendix X1 See Appendix X2 Density ASTM F2026 ASTM D1505 kg/m3 1280-1320 1294 Chemical Properties Total Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), max ASTM F2026 US Pharmacopeia, ppm BIOMATERIAL PROPERTY

Medical-grade, biocompatible PEEK polymer materials Implantable PEEK rods have shown remarkable felicities over typical biomedical implants such as metallic alloys, ceramics, and polyethylenes. PEEK is now used to design medical implants in joint replacement systems, spine implants, and cages in vertebral fusion surgeries. Our wide range of biocompatible polymer materials and compounds are each designed to meet the specific and rigorous demands of implantable medical devices. PEEK materials are tailored to offer superior performance in a variety of applications including spine, orthopedic, trauma, dental and specialty devices. Innovative PEEK materials and our in-depth manufacturing knowledge combined with application expertise supports medical device companies to bring leading edge devices to market and open up new areas of growth. Properties Information Property Reference Standard Test Method Unit Specification Result Physical Properties Glass Transition ASTM F2026 ASTM D3418 °C 125-165 147 Temperature, Tg Melt Temperature, Tm ASTM F2026 ASTM D3418 °C 320-360 338 Recrystallization ASTM F2026 ASTM D3418 °C 260-320 289 Temperature, Tc Viscosity ASTM F2026 ISO 11443 Pa·s 400-480 437 Infrared Spectrum ASTM F2026 ASTM F1579 / See Appendix X1 See Appendix X2 Density ASTM F2026 ASTM D1505 kg/m3 1280-1320 1294 Chemical Properties Total Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), max ASTM F2026 US Pharmacopeia, ppm <100 ＜10 Test 233 Mechanical Properties Tensile Strength at Yield (zero slope), min ASTM F2026 ASTM D638, Type IV, 5.08 cm/min MPa 90 105 Tensile Strength at Break, min ASTM F2026 ASTM D638, Type IV, 5.08 cm/min MPa 70 80 Elongation at Break, min ASTM F2026 ASTM D638, Type IV, 5.08 cm/min % 5 18 Flexural Strength, min ASTM F2026 ASTM D790 MPa 110 163 Flexural Modulus, min ASTM F2026 ASTM D790 GPa 3 4 Impact Strength, ASTM F2026 ISO 180 kJ/m2 4 9 Notched Izod, min Biological Properties Genotoxicity ISO 10993-3 ISO 10993-3 / Negative Negative Animal Intracutaneous (Intradermal) Reactivity ISO 10993-10 ISO 10993-10 / ≤1 0 Skin Sensitization ISO 10993-10 ISO 10993-10 / ≤1 0 Acute Systemic Toxicity ISO 10993-11 ISO 10993-11 / No Acute Systemic Toxicity No Acute Systemic Toxicity Subchronic Systemic Toxicity ISO 10993-11 ISO 10993-11 / No Subchronic Systemic Toxicity No Subchronic Systemic Toxicity local Effects After Implantation ISO 10993-6 ISO10993-6 / No obvious difference between the test sample and the control sample No obvious difference between the test sample and the control sample In Vitro Cytotoxicity ISO 10993-5 ISO10993-5 / ≤1 1 Evaluation of Haemolytic Properties ISO 10993-4 ISO10993-4 % ＜5 1 Material Mediated Pyrogens ISO 10993-11 ISO 10993-11 / No Pyrogenic Responses No Pyrogenic Responses Extractables of The Material ISO 10993-18 ISO 10993-18 μg/g The contents of Phenyl Sulfone≤300 The contents of Phenyl Sulfone＜0.09