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510(k) Testing

Orthopaedic 510(k) Testing

If you are developing new orthopaedic implants or medical devices, you need to be able to show equivalence to an existing product to be able to register through the 510(k) route. 510(k) is not a specific test method, but it does require that tests and supporting data prove the medical device is as safe and effective as its predicate device.

510(k) Testing


When is 510(k) applicable?

When your new device is made from the same materials and is similar to the design and function of the predicate medical device, then 510(k) will usually be the preferred, and fastest, route to market.

What if a medical device is significantly different?

If the design, function, or materials used in a medical device are not similar to an approved medical device, then you might need to obtain Pre-Market Approval (PMA). If you are unsure whether 510(k) is the best route for you, contact us to discuss your requirements.

Why choose Lucideon as a testing partner?

At Lucideon, we provide a one-stop-shop for all your needs. We perform testing and analytical services to USP, ISO, ASTM, and other required standards, as well as following various regulatory and testing guidance documents (e.g., FDA, AAMI, etc.). In addition to testing, we provide consultancy services to assist in preparing your 510(k) file and product registration.

The tests carried out to prove equivalence need to be relevant, thorough, and supported by rationale, ready for your submission. Our experts work with Class II, Class III, and Combination Products that incorporate a pharmaceutical component. We develop the testing strategy, perform all relevant analysis, and provide the data, complete with full interpretation and justification for why it shows equivalence.

Our core team of medical device experts are based in the United States and, along with our extensive network of global partners, we support 510(k) submissions and help navigate the FDA pathway for clients all over the world. We also operate in many other markets around the world and can test to other regulatory body requirements.

We team with strategic scientific partners who have specific, industry-leading expertise in areas including toxicology, fatigue testing, and regulatory evaluation support. This network means that we can take you from the very start right to the finish.


What analytical services does Lucideon offer?

The list below provides examples of the related analytical services we provide, and supporting services for medical devices:

Materials science is at the heart of what we do, and we can provide services for all medical device materials.

We have FDA-inspected and ISO 17025-accredited laboratories providing global support.