ReproBone

Main information

  • Trade name:
  • ReproBone novo HA Paste - Graft, bone, synthetic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ReproBone novo HA Paste - Graft, bone, synthetic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217839
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217839

Prism Surgical Designs Pty Ltd - ReproBone novo HA Paste - Graft, bone, synthetic

ARTG entry for

Medical Device Included Class III

Sponsor

Prism Surgical Designs Pty Ltd

Postal Address

PO Box 27,RED HILL, QLD, 4059

Australia

ARTG Start Date

28/11/2013

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

Ceramisys Ltd

Alison Business Centre Alison Crescent

Sheffield, , S21AS

Products

1. ReproBone novo HA Paste - Graft, bone, synthetic

Product Type

Single Device Product

Effective date

28/11/2013

GMDN

16966 Graft, bone, synthetic

Functional description

ReproBone novo is a mixture of nanocrystalline hydroxyapatite in water. It is biocompatible designed to act

as an osteoconductive medium to support ingrowth and fusion of the adjacent viable bone when placed in

an osseous environment. Will fully resorb and be replaced by natural bone due to its nanocystalline

structure.

Intended purpose

Intended to be used for filling and supporting the ingrowth of adjacent viable bone in bone defects that are

not intrinsic to the stability of the bone structure. These defects may be located in the extremities, pelvis,

spine or dental or peridontal or mandibular areas; and used for filling of bone defects in the case of

fractures, resection or benign tumours or cysts, for filling cages and for filling autograft harvest sites;

defects of the alveoloar ridge or wall inclusive extraction sockets and for filling periodontal defects.

Intended to act as a temporary scaffold and will remain as a soft paste and is not intended to provide

structural support during hte healing process. Biocompatible, radiopaque and will resorb in a controlled

way.

Variant information

Volume (mL) Packs: 3 Unit Packs

Volume (mL) Packs: 2 Unit Packs

Volume (mL) Packs: Single Unit Pack

Volume (mL) 0.5cc-15cc

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 10.11.2017 at 12:49:59 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