Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Signature Spine & Joint Pty Ltd - Tripore HA-Granules in Poloxamer (1-2 mm) - Bone matrix implant,
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.
BioCity Pennyfoot Street
Nottingham, , NG1 1GF
1. Tripore HA-Granules in Poloxamer (1-2 mm) - Bone matrix implant, synthetic
Medical device system
17751 Bone matrix implant, synthetic
TriPore Putty contains synthetic hydroxyapatite bone graft granules suspended in aqueous polymer carrier
gel. Tripore is designed to fill bone voids and act as a bone graft extender / expander. Tripore is supplied
in a delivery applicator to facilitate the delivery directly into the defect site, or the user may dispense into
the hand for manual manipulation.
Any spinal surgical procedure requiring bone-graft where the use of autograft would be precluded either
due to the secondary effects of graft harvest (e.g. pain, disfigurement etc) or lack of autograft. This would
include spinal fusion surgery in the postero-lateral gutter. TriPore Putty is designed for spinal use acting as
a bone graft extender / expander in non-weight-bearing applications. If weight-bearing is anticipated the
graft site will need to be protected by supplemental internal and/or external fixation. For use in skeletally
mature patients, only.
Model number (see guidance
Volume (mL) 5, 10
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 02.11.2019 at 06:12:24 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information