Tripore HA-Granules in Poloxamer (1-2 mm) - Bone matrix implant, synthetic

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Signature Spine & Joint Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
322207

Public Summary

Summary for ARTG Entry:

322207

Signature Spine & Joint Pty Ltd - Tripore HA-Granules in Poloxamer (1-2 mm) - Bone matrix implant,

synthetic

ARTG entry for

Medical Device Included Class III

Sponsor

Signature Spine & Joint Pty Ltd

Postal Address

17 / 105A Vanessa Street,KINGSGROVE, NSW, 2208

Australia

ARTG Start Date

23/08/2019

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Orthogem Ltd

BioCity Pennyfoot Street

Nottingham, , NG1 1GF

United Kingdom

Products

1. Tripore HA-Granules in Poloxamer (1-2 mm) - Bone matrix implant, synthetic

Product Type

Medical device system

Effective date

23/08/2019

GMDN

17751 Bone matrix implant, synthetic

Functional description

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.

Intended purpose

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.

Variant information

Model number (see guidance

docs) 2102-1205,2102-1210

Volume (mL) 5, 10

Specific Conditions

© 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.

Public Summary

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

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