Before the first submission
Regulatory strategy and testing plan, listed in 4 days
DKS Ortho makes knee implants in India. They wanted to sell in the US. First they needed to know what the testing would cost.
- To a written plan and the full test list
- 4 daysTo a written plan and the full test list
- For Complizen to classify the devices and find the FDA path
- SecondsFor Complizen to classify the devices and find the FDA path
- Testing runs now, at labs we found for them
- In progressTesting runs now, at labs we found for them
- Company
- DKS Ortho
- Device
- Knee replacement systems
- Based in
- India
- Came to us
- Before the first submission
A full knee product line, and no US plan
DKS Ortho makes knee replacement systems in India. They sell in several countries, but not in the US. They wanted a 510(k).
Before they started, they wanted a real answer to one question: what will this cost us? Testing is the largest cost in most orthopedic submissions, and the list of tests is long. A vague answer is worse than no answer, because people build a budget on it.
We made the plan first, then priced the work
We wrote the regulatory strategy: the device class, the FDA path that follows from it, and predicate devices we can defend to FDA.
Then we ran a gap assessment against that strategy. Complizen listed everything the path requires and compared it to the documents DKS already had from other markets. The result was a clear list of tests. Nothing vague, and nothing added to raise the price.
Our regulatory team validated and confirmed the list. DKS had the strategy and the list in four days.
Testing, at labs we found for them
Finding the right laboratory takes real work. It has to test orthopedic implants to FDA standards, have free time in its schedule, and be willing to work with a manufacturer in another country. We introduced DKS to labs that do all three.
We manage that testing now. We build the 510(k) when the results arrive, not before.
What DKS Ortho got
- A regulatory strategy: device class, FDA path, and predicate devices
- A gap assessment run against that strategy
- The full list of tests the path requires
- Introductions to testing laboratories
- The testing process, managed for them
Where it stands
Testing is running now. We build and send the 510(k) when the results arrive.
The services we used
