?-TCP Granules (GranOS) - Bone matrix implant, synthetic

Main information

  • Trade name:
  • ?-TCP Granules (GranOS) - Bone matrix implant, synthetic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ?-TCP Granules (GranOS) - Bone matrix implant, synthetic
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Included
  • Authorization number:
  • 233701
  • Last update:
  • 01-06-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

233701

Signature Spine & Joint Pty Ltd - ?-TCP Granules (GranOS) - 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

12/02/2015

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

TCM Associates Limited

3 Hillgrove Business Park Nazeing Road

Nazeing, Essex,

United Kingdom

Products

1. ?-TCP Granules (GranOS) - Bone matrix implant, synthetic

Product Type

Single Device Product

Effective date

12/02/2015

GMDN

17751 Bone matrix implant, synthetic

Functional description

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.

Intended purpose

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.

Variant information

Size (mm) 250 ± 500um

Size (mm) 500um ± 1mm

Size (mm) 2 ± 4 mm

Size (mm) 1 ± 2 mm

Volume (mL) 1cc to 30cc

Specific Conditions

No Specific Conditions included on Record

© 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 08.11.2017 at 07:13:40 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