CPCS

Main information

  • Trade name:
  • CPCS 12/14 Taper Collarless Polished Cemented Primary Stainless Steel Femoral Component - Uncoated femoral stem prosthesis, modu
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CPCS 12/14 Taper Collarless Polished Cemented Primary Stainless Steel Femoral Component - Uncoated femoral stem prosthesis, modu
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220355
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220355

Smith & Nephew Pty Ltd2/14 Taper Collarless Polished Cemented Primary Stainless Steel Femoral

Component - Uncoated femoral stem prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

21/02/2014

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

Smith & Nephew Inc Orthopaedic Division

1450 E Brooks Road

Memphis, TN, 38116

United States Of America

Products

1. CPCS 12/14 Taper Collarless Polished Cemented Primary Stainless Steel Femoral Component - Uncoated

femoral stem prosthesis, modular

Product Type

Single Device Product

Effective date

21/02/2014

GMDN

34203 Uncoated femoral stem prosthesis, modular

Functional description

A sterile, stainless steel femoral component of a total hip system. The CPCS femoral stem is intended to

be used in primary total hip replacement and features a tapered geometry, trapezoidal cross-section,

highly polished surface, a 12/14 taper and is intended to be used with bone cement.

Intended purpose

The femoral stem of the CPCS Cemented Hip System is indicated for individuals undergoing primary and

revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of

trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of

osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the

pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid

arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of

nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement

that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone

resection; fracture-dislocation of the hip; and correction of deformity.

Variant information

Length (mm) 120-135

Size 0H-5H

Size 0-5

Product name (see guidance docs) CPCS 12/14

Taper High Offset Stainless Steel

Product name (see guidance docs) CPCS 12/14

Taper Standard Offset Stainless Steel

Offset Standard and High

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 04:24:44 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