Updated 22 October 2026
Orthopaedic and spine device distributors in Australia: 21 licensed establishments
The Bastion Hale Distributor Index lists 21 establishments in Australia whose registry records include orthopaedics, spine and trauma: 0 with a channel role (importer, distributor, wholesaler or authorised representative), 3 registration holders without a channel role, and 18 registered as manufacturer or exporter only, out of 202 medical device establishments in Australia overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 3 | 14% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 18 | 86% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 7 | 33% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Australia
In Australia the ARTG entry is held by an Australian sponsor, which is usually the importer or distributor or a local subsidiary. If the distributor is the sponsor, the market entry belongs to it until a transfer is agreed.
Top 20 orthopaedics, spine and trauma establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | COCHLEAR LIMITED LANE COVE New South Wales, NSW | Holder Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +2 more | 166 | 23 | 0 | 57.8 | 3/5 |
| 2 | CARE ESSENTIALS PTY LTD. North Geelong Victoria, VIC | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Orthopaedics, spine and trauma +1 more | 31 | 2 | 0 | 38.1 | 3/5 |
| 3 | IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL) Mulgrave Victoria, VIC | Holder Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma | 15 | 2 | 0 | 36.2 | 3/5 |
| 4 | Zimmer Biomet Pty Ltd Sydney New South Wales | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +2 more | 580 | 1 | 0 | 45.2 | 3/5 |
| 5 | Merit Medical Australia Pty Ltd. Braiside Victoria | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 265 | 1 | 0 | 41.2 | 3/5 |
| 6 | Arthrex Australia Pty Ltd. Frenchs Forest New South Wales | Manufacturer Exporter | Cardiovascular, General hospital and consumables, Dental +6 more | 209 | 1 | 0 | 40.0 | 3/5 |
| 7 | INKA SURGICAL INSTRUMENTS Jandakot Western Australia | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Dental +6 more | 139 | 1 | 0 | 38.0 | 3/5 |
| 8 | SIGNATURE ORTHOPAEDICS PTY LIMITED Sydney New South Wales | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma, Surgery and endoscopy | 64 | 1 | 0 | 34.1 | 3/5 |
| 9 | OPTIMIZED ORTHO PTY LTD Sydney New South Wales | Manufacturer Manufacturer, Exporter | Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 10 | 1 | 0 | 27.3 | 3/5 |
| 10 | FIELD ORTHOPAEDICS Teneriffe Queensland | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 11 | 1 | 0 | 25.5 | 3/5 |
| 11 | Osseointegration International Pty Ltd. Macquarie Park New South Wales, New South Wales | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 3 | 2 | 0 | 25.3 | 3/5 |
| 12 | KICO KNEE INNOVATION COMPANY Frenchs Forest New South Wales | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 10 | 1 | 0 | 25.1 | 3/5 |
| 13 | Cochlear Limited - Brisbane Newstead Queensland | Manufacturer Manufacturer | Ear, nose and throat, Orthopaedics, spine and trauma, Surgery and endoscopy | 8 | 1 | 0 | 24.1 | 3/5 |
| 14 | ACTIS MEDICAL Torrensville South Australia | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma | 5 | 1 | 0 | 22.0 | 3/5 |
| 15 | MAC SURGICAL Brookvale New South Wales | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 4 | 1 | 0 | 21.1 | 3/5 |
| 16 | Gyder Surgical Pty Ltd Mulgrave Victoria | Manufacturer Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma | 2 | 1 | 0 | 20.8 | 3/5 |
| 17 | DORSAVI LTD Oakleigh South Victoria | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 3 | 1 | 0 | 20.0 | 3/5 |
| 18 | Saluda Medical Pty. Ltd. Macquarie Park New South Wales | Manufacturer Manufacturer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +1 more | 3 | 1 | 0 | 20.0 | 3/5 |
| 19 | PRECISION AI PTY LTD Brisbane Queensland | Manufacturer Manufacturer | Orthopaedics, spine and trauma | 2 | 1 | 0 | 18.5 | 3/5 |
| 20 | RELAX RETRACTORS Kingswood New South Wales | Manufacturer Manufacturer | Orthopaedics, spine and trauma | 2 | 1 | 0 | 18.5 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in Australia
How many orthopaedics, spine and trauma distributors are there in Australia?
The Index counts 21 establishments in Australia with orthopaedics, spine and trauma in their registry record, of which 0 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in Australia?
In Australia the ARTG entry is held by an Australian sponsor, which is usually the importer or distributor or a local subsidiary. If the distributor is the sponsor, the market entry belongs to it until a transfer is agreed.
How do I find a orthopaedics, spine and trauma distributor in Australia?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Australia to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a orthopaedics, spine and trauma distributor in Australia?
A company that appears in a public regulatory registry with an address in Australia and whose linked device listings fall in the orthopaedics, spine and trauma segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Australia
Orthopaedics, spine and trauma in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 21 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 4 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.