(takes approx. 3 min)
To create a tailored test plan, please provide some information about your device.If you’re unsure about a question, just leave it blank.
This generator is free to use. Please note that it is supplementary to the expertise of an RA professional.We strongly recommend discussing the generated plan with your targeted regulatory authority before submission.
All information you provide will be used solely for generating your test plan and will not be shared with third parties. If you require an NDA beforehand, please reach out via the contact form.
Once complete, you will receive a copy of your responses along with the generated test plan by email.
Cruciate Retaining Knee Implant
This design preserves the posterior cruciate ligament (PCL) to maintain more natural knee kinematics. It is often used when the patient’s ligaments are healthy and stable.
Posterior Stabilised Knee Implant
PS knees replace the function of the PCL with a cam-and-post mechanism in the implant, improving stability when the ligament is removed.
Ultra-Congruent / Medial-Pivot Knee Implant
Ultra-congruent and medial-pivot femoral designs are alternatives to posterior-stabilised systems. Instead of using a post-cam mechanism, they rely on highly conforming tibial inserts to provide stability. Their goal is to better replicate natural knee kinematics.
Hinged Knee Implant
This design provides a mechanical hinge for stability in severe cases of instability, deformity, or bone loss. It is typically used in revision or complex surgeries.
Knee Augment / Cone / Flange
There is a variety of accessory options that can be used alongside a knee replacement. Please select this option if you are developing such an implant.
Novel Implant
We are excited to help you bring your innovative ideas to market. With our expertise in biomechanics, we design tailored procedures that meet your specific needs.
Stemmed designs need careful evaluation of corrosion and fatigue properties.
Specific tests may be needed for the locking mechanism.
Please specify any system components that may also need to be tested. This will allow us to develop a tailored testing plan for you.
Please let us know where you intend to market your device so we can take into account the specifics of the relevant approval processes.Our reports are accepted internationally and well-known by authorities like the FDA and PMDA.