Medical device information
Medical device information for ChondroFiller.
The manufacturer, UK Responsible Person, register status, conformity, intended purpose, formats and vigilance route for ChondroFiller® liquid.
Manufacturer
Manufactured by Meidrix Biomedicals GmbH.
ChondroFiller is manufactured by Meidrix Biomedicals GmbH, Esslingen, Germany.
UK Responsible Person
Actomed Ltd, Grantham.
UK Responsible Person: Actomed Ltd, The Old Barracks, Sandon Road, Grantham NG31 9AX.
Register status
Listed on the MHRA register.
The manufacturer is listed on the MHRA register of medical devices, with Actomed named as UK Responsible Person. Registration is not approval.
Conformity
CE marked by the manufacturer.
CE marked by the manufacturer; accepted on the Great Britain market under the current transitional arrangements for CE-marked devices. Current instructions for use remain authoritative.
The product label carries the CE mark with notified body number 0483.
Intended purpose
As stated by the manufacturer.
The manufacturer's patient information states: ‘The application is intended to be used for filling clearly delimited cartilage damage up to grade IV in joints such as the knee, hip, shoulder and ankle as well as in partial cartilage injuries, subchondral and osteochondral defects. The implant offers the patient's own cells the opportunity to migrate into the matrix for the associated tissue regeneration. At the same time it serves as protection against further cartilage degeneration. Use in other parts of the body, such as auricle or breast, is not permitted.’
Formats
Available pack sizes.
| Property | Value |
|---|---|
| Formats | 1.0 ml, 1.5 ml, 2.3 ml |
| Presentation | Supplied as a ready-to-use dual-chamber syringe: a collagen solution and a neutralising solution mixed through an adapter at the point of application. |
| Setting time | The mixed matrix hardens into a hydrogel in approximately 3 to 5 minutes, per the manufacturer. |
Information on this site
Two sections, written for two audiences.
The patient section of this site gives general information for patients and carers. It is not clinical advice and does not replace an assessment by a clinician.
The professional section is written for UK healthcare professionals and covers composition, indications, contraindications, handling, technique and evidence. Current instructions for use remain authoritative.
Vigilance route
Report to Actomed.
Report a suspected adverse event or product quality issue to Actomed, the UK Responsible Person, who passes reports to the manufacturer and, where required, to the MHRA.