Yes and No. Since PSI’s are designed specifically for each patient, a lot of labor is involved and they cannot be mass produced; this translates to a higher initial price. However, because of the many benefits of PSI’s, they are eventually the cheaper option if you compare the total and long term costs.
Patient Specific Implants are medical devices, most countries require import documents and their own approval. Please contact us to discuss the possibilities.
Anatomical models do not have these restrictions and can be shipped anywhere.
Medical Device Directive states that patient specific implants are categorized as; “Custom made devices, which means: any device specifically made in accordance with a fully qualified medical practitioner’s written prescription who gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.”
“Custom-made devices being placed on the market to be put into service cannot bear the CE marking”
Also under the new MDR, custom-made devices cannot be CE-marked.
Quality and patient safety are important and therefore Xilloc is certified according to ISO13485:2016
As all our products are custom made to a specific patient, therefore prices can differ greatly.
To get a free quotation, please upload the CT-scan data to our MedX system.
Within Xilloc we put quality upfront, we utilize state of the art materials and production processes certified according to ISO 13485.
Yes, if for research or other reasons, we can just provide you with a PSI design.
Yes, you are welcome to send in your design for production by us. We can provide you with a second design opinion and produce it in one of our materials you prefer and ship it to you. However, we do not take responsibilty for your design.