Implant testing

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Hip implants

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ISO 21535

ASTM F1820

Disassembly forces of modular acetabular devices
Icon of the ASTM F1875 test

ASTM F1875

Fretting corrosion testing of modular implants – Femoral stem-head interface
Icon of the ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

ASTM F2009

Modular connection disassembly test

ASTM F2068 (PI-98)

Requirements for femoral prostheses - Metallic implants

ASTM F2345

Femoral head fatigue test

ASTM F2580

Modular stem fatigue test

ASTM F2582

Impingement test

ASTM F2979

Bearing surface characterization of retrieved hard-on-hard hip prostheses

ASTM F2996

FEA non-modular hip femoral stem

ASTM F3018

Guide for assessment of hard-on-hard articulation THR devices

ASTM F3047M

High demand hip wear testing

ASTM F3090

Fatigue test of acetabular devices

ASTM F3446

3D frictional torque measurement of total hip joint prostheses

ASTM F3738

Third body hip wear test

ISO 11491

Impact resistance femoral heads

ISO 14242-1

Hip wear test

ISO 14242-4

Microseparation test

ISO 21534

Particular requirements for joint replacement implants
Icon of the ISO 21535 test

ISO 21535

Hip range of motion
icon test description

ISO 21535

Specific requirements for hip-joint replacement implants

ISO 7206-1

Classification and designation of dimensions

ISO 7206-10

Femoral head compression test

ISO 7206-12

Deformation test for acetabular shells

ISO 7206-13

Femoral head torsion test

ISO 7206-2

Hip surface analysis

ISO 7206-4

Femoral stem fatigue test

ISO 7206-6

Femoral stem neck fatigue test

ISO 7206-8

Femoral stem fatigue test

PI-11

Insert compression fatigue / static test

PI-3

Acetabular cup luxation test

PI-58 (ISO 7206-8)

Femoral stem fatigue test

PI-87

FEA non-modular hip femoral stem - neck region

PI-99 (ASTM F2091)

Standard specification for acetabular prostheses

ISO 21535

Specific requirements for hip-joint replacement implants

Normative References

ISO 21535: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint implants  

ISO 21535 has been fundamentally revised. It now serves as the go-to standard for all hip devices, and includes the relevant ASTM procedures. For submission to regulatory bodies worldwide, ISO 21535 (the so-called “hip umbrella standard”) is now the applicable guideline.

Additionally, the standard outlines the evaluation process for test results, which involves a multi-stage procedure. In particular, it requires the use of a reference implant (predicate device), which presents manufacturers with fundamentally new requirements.

Our specialists will be happy to assist you in selecting the worst-case combinations for testing and to be tested and in developing a test plan that meets the requirements of ISO 21535.  

Resources

Need help selecting which tests within ISO 21535 apply to your device? Use our test plan generator to filter the relevant tests for your specific device – Welcome to the hip implant test plan generator!

Normative Navigator Hip - new Layout (#11)

(takes approx. 4 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.

Please specify the device type

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.

Please give us some additional information

Femoral stem

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.

Femoral head

Specific tests may be needed for ceramic heads. 

Acetabular cup

The acetabular cup design is relevant for gravimetric measurement and embedding. If you have multiple coating options, please select all of them.

Acetabular liner

The acetabular liner influences wear measurement. Locking strength may need to be assessed.

Additional components

Please specify any system components that may also need to be tested. This will allow us to develop a tailored testing plan for you.

Regulatory details

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.

How may we contact you?

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

Head of Fatigue Testing & Material Analysis, Head of Vascular Testing