Prosthesis

Main information

  • Trade name:
  • Prosthesis, internal, ligament, anchor
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Prosthesis, internal, ligament, anchor
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217339
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217339

Smith & Nephew Pty Ltd - Prosthesis, internal, ligament, anchor

ARTG entry for

Medical Device Included Class IIb

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

15/11/2013

Product category

Medical Device Class IIb

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

Arthrocare Corporation

7000 West William Cannon Drive

Austin, TX, 78735-8531

United States Of America

Products

1. Prosthesis, internal, ligament, anchor

Product Type

Single Device Product

Effective date

15/11/2013

GMDN

36174 Ligament anchor

Intended purpose

The device is intended to be used for soft tissue to bone fixation for:

Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral

reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis

Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus

reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair

Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon

reattachment

Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and

posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus

advancement (VMO); joint capsule closure

Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in

phalanx; Volar plate reconstruction

Hip: Acetabular labral repair

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 02:36:15 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