Medical PEEK Material Rod Implant PEEK Bar

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.

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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, T_g	ASTM F2026	ASTM D3418	°C	125-165	147
	Melt Temperature, T_m	ASTM F2026	ASTM D3418	°C	320-360	338
	Recrystallization	ASTM F2026	ASTM D3418	°C	260-320	289
	Temperature, T_c	ASTM F2026	ASTM D3418	°C	260-320	289
	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
Chemical Properties		ASTM F2026	Test 233	ppm	<100	＜10
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	ASTM F2026	ISO 180	kJ/m²	4	9
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

TAGS: PEEK Medical