Arcos

Main information

  • Trade name:
  • Arcos modular hip revision system Bonemaster calcar proximal body type 1 taper - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Arcos modular hip revision system Bonemaster calcar proximal body type 1 taper - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222626
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222626

Zimmer Biomet Pty LtdPty Ltd - Arcos modular hip revision system Bonemaster calcar proximal body type 1

taper - Coated hip femur prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

17/04/2014

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

Biomet Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Arcos modular hip revision system Bonemaster calcar proximal body type 1 taper - Coated hip femur

prosthesis, modular

Product Type

Single Device Product

Effective date

17/04/2014

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

Bonemaster hydroxyapetite and porous coated titanium alloy proximal femoral calcar body with Type 1

taper; designed for cases where proximal femoral support is desired (Type IIIa, IIIb, IIIc femoral defect); 3

resection level options; standard and high offset options to reproduce patient anatomies without leg

lengthening; trochanteric reattachment bolt hole; 2 vertical height options.

Intended purpose

Bonemaster hydroxyapetite and porous coated titanium alloy calcar proximal femoral body intended for

use as one component of the Arcos modular hip revision system. Indications for use: Non-inflammatory

degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction

of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the

proximal femur with head involvement, unmanageable using other techniques; revision of previously failed

total hip arthroplasties. Intended for uncemented use only

Variant information

Product name (see guidance docs) Calcar Shelf +10

Product name (see guidance docs) Calcar Shelf +0

Height (mm) 60

Height (mm) 50

Offset High

Size A-F

Offset Standard

Product name (see guidance docs) Calcar Shelf +20

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 09.11.2017 at 08:48:15 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