Summary for ARTG Entry:
Prism Surgical Designs Pty Ltd - ReproBone novo HA Paste - Graft, bone, synthetic
ARTG entry for
Medical Device Included Class III
Prism Surgical Designs Pty Ltd
PO Box 27,RED HILL, QLD, 4059
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.
Alison Business Centre Alison Crescent
Sheffield, , S21AS
1. ReproBone novo HA Paste - Graft, bone, synthetic
Single Device Product
16966 Graft, bone, synthetic
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
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
Volume (mL) Packs: 3 Unit Packs
Volume (mL) Packs: 2 Unit Packs
Volume (mL) Packs: Single Unit Pack
Volume (mL) 0.5cc-15cc
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:49:59 AEDT
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