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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.
Standard Hip Implant
This design involves replacing both the femoral head and the acetabulum. A stem is inserted into the femur, topped with a femoral head, which fits into an artificial acetabular cup placed in the pelvis. It is the most common form of hip replacement.
Bipolar Hip Implant
Bipolar hips consist of a small (metal) femoral head that fits into a larger bipolar head usually lined with polyethylene, which then articulates with the patient’s natural acetabulum. This dual-bearing system helps decrease wear, reduce acetabular erosion, and improve mobility compared to unipolar implants.
Dual Mobility Hip Implant
This design features two points of articulation. A small femoral head articulates inside a larger dual mobility head, which itself moves within the (metal) acetabular shell. This dual movement increases the range of motion and significantly reduces the risk of dislocation, making it useful for patients at higher risk of instability.
Hip Augment / Shim / Flange
There is a variety of accessory options that can be used alongside a hip replacement. Please select his options if you are developing such an implant.
Resurfacing Implant
The resurfacing technique preserves more of the patient’s natural bone by capping the femoral head with a metal shell instead of replacing it with a stem and artificial head. The acetabulum is fitted with a matching cup. This technique is often used in younger, more active patients because it maintains bone stock, which can be advantageous if future revisions are required.
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.
The stem design has implications for embedding and corrosion analysis. If there is a variety of different designs in your system, please select all of them. If you have multiple coating options, please select all of them.
Specific tests may be needed for ceramic heads.
The acetabular cup design is relevant for gravimetric measurement and embedding. If you have multiple coating options, please select all of them.
The acetabular liner influences wear measurement. Locking strength may need to be assessed.
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.
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