uDesis Gel synthetic bone substitute - Bone matrix implant, synthetic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Precision Surgical Pty Ltd

Class:

Class III

Manufactured by:

TCM Associates Limited Unit 3 Hillgrove Business Centre Nazeing Road, NAZEING , ESSEX , EN9 2HB United Kingdom

Therapeutic area:

17751 - Bone matrix implant, synthetic

Therapeutic indications:

uDesis Gel contains porous resorbable bTCP granules that create an osteoconductive scaffold for new bone growth. The granules are constructed of highly pure beta-tricalcium phosphate suspended in an aqueous polymer. The gel should be implanted directly into bony voids or defects of the skeletal system. The water soluble carrier gel then dissolves leaving behind the calcium phosphate matrix which is resorbed and replaced with bone during the healing process. uDesis Gel is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bone void or gaps that are not intrinsic to the stability of the bone structure, i.e. subjected to low load or compressive loading. If osseous defects are intrinsic to the stability or integrity of the skeleton, mechanical stability must be addressed prior to use. uDesis indicated for use in place of corticocancellous, or cancellous or autograft bone. Typical applications for bone substitutes are: Bone void filling following surgery, typical surgical techniques include: . Small void filling, e.g. after removal of a bone tumor or following bone fracture reduction or in osteotomies. . Spinal fusion, where an interbody cage or mechanical fixation is used concurrently to relieve the graft site from load. . Osseous defects created from traumatic injury to the bone. . Bone void filling following removal of a cyst or tumor.

Authorization status:

A

Authorization date:

2021-01-18