We help our clients gain regulatory approval for total and partial knee replacement medical devices
We offer a broad range of static, dynamic, computational, and wear testing services for total and partial knee replacement devices. All of our test procedures follow international test standards as described below.
Our engineering team is active in ASTM and ISO arthroplasty standards committees to ensure the latest industry best-practices are applied to your test. If a non-standard test is needed, our engineering team will develop and incorporate modifications to suit your specific device and data needs.
Having a strong foundation in clinical research provides you with the additional value of a clinically-relevant test procedure. We pride ourselves on the ability to meet a customer’s specific needs with a wholly unique, tailored solution.
Total Knee Replacement Constraint TestingThis test method measures the constraint on total knee replacements under specific loading conditions. These include constraint determination in: antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction. Samples are loaded in the specified directions and displacement is measured. | |
Standard Patellar Component SpecificationsThis standard describes the materials, geometries, and performance requirements for patellar resurfacing devices. The standard lists relevant failure modes that should be tested and considered when determining the safety and efficacy of the knee device. The OIC can perform a series of static and dynamic testing for shear and stress analysis, and to evaluate contact area and pressure distributions. Additionally, the durability of the patellofemoral device can be tested according to ISO 14243-5. | |
Tibial Tray Fatigue TestingSimilar to ISO 14879, this standard describes cyclic fatigue testing for tibial trays. To simulate worst-case loading conditions where the medial side becomes unsupported by bone, the tibial tray is fixed unilaterally down the center line and the medial side is left unsupported. Cyclic loading is applied to the medial side for 10 million cycles or until failure. | |
Modular Knee Implant Testing GuideThis guide suggests areas of modular hip and knee implants for design evaluation and testing. The modular connections may be tested in static to measure forces during assembly (axial and torsional) and disassembly (axial, shear, bending, and torsional). Modular connections shall also be tested in cyclic fatigue to assess how the design withstands and is affected by cyclic loading while considering other factors such as sterilization, corrosion, and fretting. Our team can help determine and perform the applicable test methods on the modular connections of your total knee system. | |
Standard Specifications for Knee DevicesThis standard describes the generic types of knee devices including total knee replacements (TKR) and unicondylar knee replacements (UKR) for both fixed and mobile bearing varieties, and for primary and revision surgeries. The OIC can perform the various test methods referenced in this standard to assess knee device performance, such as: ASTM F1800, ASTM F2777, ASTM F1223, ASTM F2724, ASTM F1814, ASTM F2722, ASTM F2723, and ISO 14243-1/-3. The standard also includes contact area and contact pressure distribution testing to examine the area and magnitude of stresses applied between the femoral component and tibial insert of a total knee replacement at various flexion angles through mapping on pressure films. | |
Tibial Baseplate/Insert Resistance to Dynamic DisassociationTest method for evaluating the potential of mobile TKR bearing disassociation under repeated forces at high flexion. Five samples are tested for a total of 220,000 cycles, equivalent to 30 extreme motions per day for 20 years, or until failure of the retention mechanism. | |
Test Method for Evaluating Mobile Bearing Knee DislocationTest method to determine the dislocation resistance (constraint) of mobile-bearing TKR designs with regards to femoral component disassociation and behavior of the knee insert. Testing is performed at 4 different flexion angles and the mode of failure (either spin-out or spit-out) is reported for each angle. | |
Tibial Insert Endurance and Performance Under High FlexionTest method describing fatigue testing of tibial inserts at high-flexion angles of the femoral component. Five TKR samples are tested for 220,000 cycles or until failure. Pre- and post-test analysis of material deformation and damage are performed using a Coordinate Measuring Machine (CMM). Inserts shall be artificially aged according to ASTM F2003. | |
Fatigue Testing of Unicondylar Tibial Tray ComponentsTest method describing fatigue testing of unicondylar tibial tray components supported at only anterior and posterior edges by thin rollers. Cyclic loading is applied to the midline of the tibial tray using a spherical indenter and polymer spacer for 10 million cycles or until device failure. | |
Total Knee Replacement Loading ProfilesProvides a guide for waveforms and loading profiles that approximate activities of daily living to be applied in a TKR joint simulator. Profiles are described for: straight walking gait, stair ascent, stair descent, sit to stand to sit, pivot turn, and crossover turn. These profiles can be used in OIC’s AMTI Knee Simulator. | |
Fatigue Testing of TKR Femoral Components Under Closing ConditionsFatigue testing applied to the medial condyle of a femoral TKR component in an inverted position to simulate single condyle loading at 90° knee flexion. The femoral component is potted to a defined depth which leaves the regions of highest stress exposed to the test. Cyclic loading is applied until run-out is achieved or device failure. This standard is still in development. | |
Endurance Properties of Tibial TraysSimilar to ASTM 1800, this standard describes cyclic fatigue testing of tibial trays for 10 million cycles, or until failure. The tibial tray is mounted at the center line, with the medial side left unsupported, and the load applied on the unsupported region. | |
ISO 14243-1 Load-Control Knee Wear Test and ISO 14243-3 Displacement-Control Knee Wear TestJoint simulator wear testing evaluates the wear performance of TKR prosthesis design and bearing materials under physiological conditions for device optimization and to meet regulatory requirements. Up to 6 TKR implants can be assessed on OIC’s AMTI Knee Simulator. Samples complete 5 million cycles of testing under force-controlled (ISO 14243-1) or displacement-controlled (ISO 14243-3) kinematics. Wear is measured through gravimetric analysis following ISO 14243-2. Typical additions for this test are accelerated aging of polyethylene components (ASTM F2003), wear particle characterization (ASTM F1877), surface roughness characterization, and CMM measurement to evaluate dimensional changes resulting from the test. Adverse condition testing is also commonly performed to evaluate TKR device performance under non-ideal conditions such as increased load, high range of motion, and roughened or pre-damaged articular surfaces. | |
ISO 14243-5 Durability Performance of the Patellofemoral JointDurability of the patellar and femoral components are tested through joint wear simulation that follows a squatting sub-cycle and two low flexion sub-cycles. Loading and displacement waveforms are applied for 50,000 cycles or until patellofemoral joint failure occurs in the form of delamination, cracking or other mechanical failure. It is recommended to test the largest femur with the smallest patella to achieve the highest contact stress and subsurface shear for worst-case conditions. | |
Specification for Surface Finish of Knee ReplacementsDefines the measurement procedure for assessing surface roughness at multiple locations on a knee replacement component. This standard applies to partial and total knee replacements made of metallic, ceramic, and polymeric materials. |