September 27, 2021

Patient-specific (custom-made) implants do not have CE mark

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> > Frequently Asked Questions Frequently Asked Questions

1.
What data surgeon has to transfer for making patient-specific implant order.
2.
How can I send patient’s radiological data.
3.
How you assure the quality of patient-specific implants.
4.
What technology and materials you are using to produce patient-specific medical devices.
5.

Do patient-specific implants have CE mark

6.
What is the average lead time for patient-specific medical device.
7.
What is included in patient-specific medical device package.
8.
Can you supply patient-specific implants for urgent cases.
For designing and manufacturing patient-specific implants we require the following information from surgeon’s side: Patient’s radiological data (Usually CT)*;.
Filled order form, including specifications for implant design, delivery, etc.*.
* After contacting us, surgeon will get an order form that has to be filled, and CT scanning protocols with recommendations for scanning parameters.

There are several ways to transfer patient’s radiological data: PACS

The PACS of healthcare institution can connect to our PACS

but a special configuration is needed.
Contact us if you would prefer this option.
Virtual file storage / transfer servers.
You can send data using virtual file storage/ transfer servers, i.e.
Dropbox.
Digital storage.
You can send data in CD, DVD or USB key storage devices, via mail or courier.
Our contact information you can find here.
Keeping confidentiality of patient’s personal information, radiological data can be sent anonymized, otherwise, we will anonymize data after receiving it from a surgeon.
If have questions or you prefer to use other option, please contact our team.
The processes of patient-specific implants and single-use surgical instrument production are certified by Det Norske Veritas and fully meets the requirements of the ISO 13485 standard.
Each group of patient-specific implants (hip joint implants, temporomandibular joint endoprosthesis, etc.) is registered in the State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania.
For the design and production of patient-specific medical devices, the company uses only EU certified biocompatible materials and the state-of-the art design and manufacturing technologies.
Each manufactured component undergoes quality control processes.
More information on quality control you can read.
Patient-specific implants are manufactured using the following technologies and materials: Additive manufacturing (3D printing) technology DMLS (Direct Metal Laser Sintering); material: medical titanium alloy Ti6Al4V;.

5+1 axis milling technology; materials: UHMWPE and MP-1™;

Patient-specific surgical guides manufactured using the following technology and material: Additive manufacturing (3D printing) technology SLS (Selective Laser Sintering); material: biocompatible polyamide Nylon 12 (PA2200).
More about technologies and materials used in manufacturing of patient-specific medical devices you can find here.

CE marking is used for standard products

Patient-specific (custom-made) implants do not have CE mark.
According to Medical Device Directive (MDD) 93/42/EEC,“ custom-made medical device – Any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient”.
Patient-specific (custom-made) implants must comply with the relevant essential requirements established in MDD as applicable to ensure their safety.
Our implants are registered in the State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania as medical devices that fully comply MDD and Lithuanian Medical Norm MN 4:2009 “Medical Devices Safety Technical Regulation”.
The lead time to design and manufacture a patient-specific implant or surgical guide depends on the complexity of a clinical case and the surgeon’s requirements for the device.
Typically, the delivery terms (after surgeon approves the final design) are approximately 4 weeks for implants, and 1-2 weeks for surgical guides.
The composition of patient-specific implant packages you can find here, in each product section:.

Temporomandibular Joint Endoprosthesis

Yes, we can design and manufacture patient-specific implants in a shorter than usual timeframe.
Please contact our team for your special needs.

Ortho Baltic Implants Taikos Ave

131A Kaunas 51124, Lithuania Tel.

+370 37 473970 Fax +370 37 473 863 Message Location

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