Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Epoca Metalback Glenoid - Prosthesis, internal,
joint, shoulder, glenoid component
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class III
- 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.
Oberdorf, , 4436
1. Epoca Metalback Glenoid - Prosthesis, internal, joint, shoulder, glenoid component
Single Device Product
36259 Prosthesis, internal, joint, shoulder, glenoid component
The metal back glenoid component is used in conjunction with a UHMPE glenoid implant on the glenoid
side and is then articulating with either a resurfacing head or a humeral head / humeral stem assembly.
The metal back glenoid may be fixed with 3.5 mm cortex screws at the bottom of the pegs for additional
stability. It is for cementless application.
The metal back glenoid is a component of the Epoca shoulder prosthesis system and is intended for use
as a hemi- or total shoulder replacement. It ensures congruent glenohumeral implant surfaces to achieve
normal range of motion; Reduced size and beveled rim for normal mobility and reduced risk of
Diameter (mm) 42 to 54mm
No Specific Conditions included on Record
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