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Large Joint Implant Testing
Large Joint
Implant Testing
The renowned medical testing laboratories at Knight Testing, LLC provide a variety of testing solutions for the medical/orthopedic industry. This includes knee implant testing for FDA and regulatory approval.
In addition to performing these tests, our team of experts will guide you through the required tests for your device and continue providing support to address any questions that arise during the regulatory evaluation process.
Here’s a list of commonly tested knee replacement components below.
- Hip stems (cemented, press fit, modular)
- Acetabular shells and liners
- Taper connections
- Tibial trays and liners
- Femoral components
- Unicondylar components
Large Joint Implant Testing Services and Standards
Mechanical testing for large joints such as knee implants is multifaceted, with standards to address fatigue properties of load bearing members, disassembly forces between mating components, range of motion between articulating and sliding components, and wear debris generated from relative motion.
Here’s a list of specific testing services for knee replacement devices:
- Tensile Testing
- Compression Testing
- Fracture Toughness Testing
- High Cycle Axial Fatigue Testing
- Low Cycle Axial Fatigue Testing
Below is a list of knee implant testing standards offered by our laboratories:
- ASTM F1223 — Standard Test Method for Determination of Total Knee Replacement Constraint
- ASTM F1800 — Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
- ASTM F2009 — Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- ASTM F2345 — Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
- ASTM F2777 — Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
- ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses
- Part 4: Determination of endurance properties and performance of stemmed femoral components
- ISO 7206-6: Implants for surgery — Partial and total hip joint prostheses
- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
- ISO 7206-10: Implants for surgery — Partial and total hip-joint prostheses
- Part 10: Determination of resistance to static load of modular femoral heads
Regulatory Approval
The experts at Knight Testing specialize in testing large joints such as hip and knee replacement implants, as well as other orthopedic devices.
The test reports prepared by our experts are routinely used for submission to the FDA as well as global regulatory bodies across Europe, South America, and Asia.
We provide testing on these devices as well as continued support following your device’s submission for regulatory approval.
If you’d like to know more about our knee implant testing services, contact us for a fast quote.