Active

Main information

  • Trade name:
  • Active Knee Femoral Implant (Cemented) - Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Active Knee Femoral Implant (Cemented) - Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217122
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217122

Advanced Surgical Design & Manufacture Limited - Active Knee Femoral Implant (Cemented) - Uncoated

knee femur prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Allegra Orthopaedics Limited

Postal Address

PO Box 72,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

12/11/2013

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

Allegra Orthopaedics Limited

Unit 2 / 12 Frederick Street

ST LEONARDS, NSW, 2065

Australia

Products

1. Active Knee Femoral Implant (Cemented) - Uncoated knee femur prosthesis

Product Type

Single Device Product

Effective date

12/11/2013

GMDN

32831 Uncoated knee femur prosthesis

Functional description

The femoral component is an anatomic, asymmetrically designed prosthesis manufactured from cast

cobalt-chromium-molybdenum (CoCrMo). The design incorporates a trochlear groove, which conforms to

the geometry of the patellar prosthesis and allows for sliding articulation. The cemented femoral implant

has a grit blast finish on the interior surfaces for enhanced polymethylmethacrylate (PMMA) fixation.

Intended purpose

The cemented femoral implant is a part of the Active Knee System for skeletally mature patients which

have adequate bone stock. Intended for Non-inflammatory degenerative joint disease including

osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including

rheumatoid arthritis; Functional deformity such as varus, valgus or flexion deformities; Revision procedures

where other treatments or devices have failed; Fractures that are unmanageable using other techniques.

Variant information

Size 1 - 5 1/2

Shape Left

Shape Right

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 03:18:35 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

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Europe -DG Health and Food Safety

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Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

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Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

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Europe -DG Health and Food Safety

8-3-2019

EU/3/15/1487 (Leadiant GmbH)

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Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1757 (Imago BioSciences B.V.)

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Europe -DG Health and Food Safety

8-3-2019

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Active substance: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11) - Transfer of orphan designation - Commission Decision (2019)1941 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004486

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1285 (Clinuvel Europe Limited)

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Europe -DG Health and Food Safety

8-3-2019

EU/3/09/648 (Clinuvel Europe Limited)

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EU/3/09/648 (Active substance: Afamelanotide) - Transfer of orphan designation - Commission Decision (2019)1949 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004299

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1948 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004293

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1947 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004019

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Active substance: 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d]pyrimidin-4-one) - Transfer of orphan designation - Commission Decision (2019)1942 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004496

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1946 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004537

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1945 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004529

Europe -DG Health and Food Safety

7-3-2019

DaTSCAN (GE Healthcare B.V.)

DaTSCAN (GE Healthcare B.V.)

DaTSCAN (Active substance: Ioflupane (123I)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1908 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/266/T/57

Europe -DG Health and Food Safety

7-3-2019

Kiovig (Baxter AG)

Kiovig (Baxter AG)

Kiovig (Active substance: Human normal immunoglobulin (IVIg)) - Centralised - 2-Monthly update - Commission Decision (2019)1909 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/628/IB/88

Europe -DG Health and Food Safety

7-3-2019

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1914 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4289/T/02

Europe -DG Health and Food Safety

7-3-2019

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

7-3-2019

Aripiprazole Accord (Accord Healthcare S.L.U.)

Aripiprazole Accord (Accord Healthcare S.L.U.)

Aripiprazole Accord (Active substance: aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1915 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4021/T/13

Europe -DG Health and Food Safety

7-3-2019

EU/3/18/2091 (S-cubed Pharmaceutical Services ApS)

EU/3/18/2091 (S-cubed Pharmaceutical Services ApS)

EU/3/18/2091 (Active substance: Glucagon) - Transfer of orphan designation - Commission Decision (2019)1740 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004177

Europe -DG Health and Food Safety

6-3-2019

Fortekor and associated names

Fortekor and associated names

Fortekor and associated names (Active substance: Benazepril hydrochloride) - Corrigendum - Commission Decision (2012)772 of Wed, 06 Mar 2019

Europe -DG Health and Food Safety