Medical device information
Medical device information for Bioport TriCombo.
The manufacturer, conformity, intended purpose, formats and vigilance route for Bioport TriCombo.
Manufacturer
Manufactured by Nikovari Bio Tech Oy.
Bioport TriCombo is a product of Nikovari Bio Tech Oy, sold under the Bioport brand.
Conformity
Conformity.
The manufacturer’s packaging carries a CE mark. UK conformity and registration details are confirmed by the manufacturer and the UK supplier before supply. Current instructions for use remain authoritative.
Intended purpose
As stated by the manufacturer.
The manufacturer’s brochure states the indication as: ‘As a viscoelastic supplement or as a replacement for the synovial fluid in the knee joint’ and ‘For the symptomatic treatment of mild to severe knee osteoarthritis’.
The manufacturer describes the intended effects as pain relief, lubrication and mechanical support, and protection and regeneration of the cartilage. These are the manufacturer’s statements; individual results vary.
Formats
Format and presentation.
| Property | Value |
|---|---|
| Formats | 2.25 ml pre-filled syringe |
| Presentation | Supplied as a single-use, pre-filled 2.25 ml glass syringe (Becton Dickinson), sterile, for intra-articular injection. |
| Treatment schedule | One syringe per treatment. The manufacturer recommends two treatment cycles per year, at six-month intervals. |
Information on this site
Two sections, written for two audiences.
Product and clinical-evidence information on this site is written for UK healthcare professionals. Patients should discuss whether TriCombo is suitable with a treating clinic. The patient section gives general information for patients and carers. It is not clinical advice and does not replace an assessment by a clinician.
The professional section covers composition, indications, contraindications, handling and evidence. Current instructions for use remain authoritative.
Vigilance
Reporting a suspected adverse event.
Report any suspected adverse event to the treating clinic and to the UK supplier, quoting the lot number from the pack. The supplier passes reports to the manufacturer.