Summary for ARTG Entry:
Signature Spine & Joint Pty Ltd - ?-TCP Granules (GranOS) - Bone matrix implant, synthetic
ARTG entry for
Medical Device Included Class III
Signature Spine & Joint Pty Ltd
17 / 105A Vanessa Street,KINGSGROVE, NSW, 2208
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
TCM Associates Limited
3 Hillgrove Business Park Nazeing Road
1. ?-TCP Granules (GranOS) - Bone matrix implant, synthetic
Single Device Product
17751 Bone matrix implant, synthetic
GranOS granules (constructed of ?-tri-calcium phosphate) create a porous, resorbable osteoconductive
scaffold, that facilitates new bone growth upon which new bone deposits and matures. Interconnected
pores within the granules, support revascularisation and cellular invasion as the regenerating bone is
guided throughout the defect. Bone forming cells are infused, enhancing the processes of new bone
development and the eventual resorption of the scaffold, as the healing process progresses.
GranOS is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or
augmenting bony voids or gaps that are not intrinsic to the stability of the bone structure i.e. subjected to
either low load or compressive loading. If osseous defects are intrinsic to the stability and integrity of the
skeleton, mechanical stability must be addressed prior to use.
Size (mm) 250 ± 500um
Size (mm) 500um ± 1mm
Size (mm) 2 ± 4 mm
Size (mm) 1 ± 2 mm
Volume (mL) 1cc to 30cc
No Specific Conditions included on Record
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Produced at 08.11.2017 at 07:13:40 AEDT
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