Harris Orthopaedics Laboratory: Testing per FDA Guidance Documents

HOL has a wide array of equipment that provides the broad range of mechanical and chemical characterizations required by the FDA for 510(k) device clearance.

This includes:

• Tensile properties (e.g. yield strength, ultimate tensile strength, and elongation at break) per ASTM D638 Type IV or V
• Impact resistance (Izod, per ASTM F648 Annex 1)
• Crosslink density per ASTM F2214
• IR spectroscopic analysis, measuring trans-vinylene index (TVI) per ASTM F2381 and oxidation index (OI) per ASTM F2102, before and after accelerated aging per ASTM F2003
• Differential scanning calorimetry, measuring crystallinity and melting temperature per ASTM F2625
• Fatigue crack propagation resistance (ΔKincep) and fatigue crack initiation resistance
• Antioxidant analysis, including elution, efficacy, and effect on properties

HOL can leverage its wide array of testing equipment and extensive expertise to investigate the latest concerns in orthopaedic materials:

• Oxidation induced by cyclic loading or absorbed lipids
  https://dx.doi.org/10.1002/jbm.b.32507
• Trunnion corrosion analysis

The HOL has the equipment needed to blend raw materials into custom formulations of polyethylene (PE) in small to medium batches for testing.

• HOL has two large 60,000 lbf capacity Carver presses to compression mold PE powder into various consolidated shapes, including blocks, cylindrical pucks, and acetabular liners tibial bearings and monoblock components.

HOL has access to local facilities to conduct additional analyses as needed, including: SEM (including EDX), TEM, AFM, NMR, XPS, μCT.