InsiteTM

Main information

  • Trade name:
  • InsiteTM FT Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • InsiteTM FT Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220714
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220714

Tornier Pty Ltd - InsiteTM FT Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable

ARTG entry for

Medical Device Included Class III

Sponsor

Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085

Australia

ARTG Start Date

5/03/2014

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

Tornier Inc

10801 Nesbitt Avenue South

Bloomington, MN, 55437

United States Of America

Products

1. InsiteTM FT Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable

Product Type

Single Device Product

Effective date

5/03/2014

GMDN

45061 Fixation anchor, soft-tissue, biodegradable

Functional description

'The Tornier InsiteTM FT Biocomposite Suture Anchor is a composite (PLLA/TCP) absorbable fully

threaded suture anchor preloaded on a disposable inserter assembly with two or three strands of braided

UHMWPE non-absorbable size #2 suture available with or without needles'

Intended purpose

Intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow repairs

and reconstructions.

Variant information

Diameter (mm) 4.5 - 6.5

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 03:21:56 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