Australia TGA ARTG record

B-TCP Gel (GelOS) - Bone matrix implant, synthetic

Australia TGA ARTG Registered Device · Pureplay Orthopaedics · TCM Associates Limited · Class III · Started February 17, 2015

Good Name: Pureplay Orthopaedics - B-TCP Gel (GelOS) - Bone matrix implant, synthetic

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: February 17, 2015
Effective Date: February 17, 2015

Sponsor

Name: Pureplay Orthopaedics

Manufacturer

Name: TCM Associates Limited
Country: United Kingdom
Address: 3 Hillgrove Business Park Nazeing Road, Nazeing, Essex, EN9 2HB

Intended purpose

GelOS is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bony voids or gaps that are not intrinsic to the stability of the bone structure i.e. subjected to either low load or compressive loading. If osseous defects are intrinsic to the stability and integrity of the skeleton, mechanical stability must be addressed prior to use.

About this record

Access comprehensive regulatory information for B-TCP Gel (GelOS) - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Pureplay Orthopaedics, manufactured by TCM Associates Limited in United Kingdom. The device registration started on February 17, 2015.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.