Company
The legal manufacturer of OPL. Built in Sydney. Trusted by clinicians on four continents.
Osseointegration International Pty Ltd is a Sydney-based medical device company. We manufacture, refine, and quality-audit every OPL implant placed by our clinical partners worldwide.
Our mission
For five centuries, the answer to limb loss has been the same: a socket. We believe the people who have been through enough deserve a better one.
The modern socket was invented by a French military surgeon in 1525. Five hundred years later, despite every refinement of liners and materials, a socket still rides on soft tissue — competing with the body rather than working with it. The result is friction, pressure, pain, and a mobility ceiling that millions of amputees have been told to accept.
OPL is different. An osseointegrated titanium implant, anchored directly into bone. The skeleton carries the load — the way it always has, the way it should. We have manufactured it, refined it, and made it available to surgical teams across four continents.
What happens next depends on the people who step forward.
History
Two decades of refinement. One continuous clinical programme.
The OPL system traces its development to the early 2000s, when Professor Munjed Al Muderis began refining osseointegrated implant geometry, surgical protocol, and rehabilitation pathway in parallel. Osseointegration International was incorporated in Sydney to take responsibility for the device as a regulated medical product.
Today OPL is the most widely implanted bone-anchored prosthetic system in the world, with active clinical centres on four continents. The implant, instrumentation, and clinical protocol have been continuously refined — current generations carry forward learnings from over two thousand patient cases.
Leadership
Built and led by people who have spent careers on this problem.
OI was founded by Professor Munjed Al Muderis, an Australian orthopaedic surgeon and one of the most experienced osseointegration practitioners in the world. The company is led day-to-day by William Lu (CEO) and a team of regulatory, manufacturing, and quality professionals based in Sydney.
Our clinical advisory network spans the surgeons, prosthetists, and rehabilitation specialists who have helped shape modern osseointegration practice over the last two decades.
Regulatory status
Approved, listed, and audited across multiple jurisdictions.
OPL is a CE-marked medical device under the EU MDR, listed on the Australian ARTG, and approved or recognised in 9+ jurisdictions. For jurisdictions not listed, please contact us to confirm device availability under your local framework.
| Region | Authority | Status | Effective |
|---|---|---|---|
| European Union | BSI (Notified Body 0086) | CE Mark — MDR | 14 Jan 2026 |
| Australia | TGA | ARTG Listed | 02 Sept 2025 |
| United Kingdom | MHRA | UKCA / CE-UK transition | 10 Nov 2025 |
| United States | FDA | Not approved for sale | — |
OPL regulatory approvals by region. Last reviewed 2026-04-24. Source: Helen / Regulatory Affairs.
Quality system
Audited, traceable, and continuously improved.
OI operates a full Quality Management System certified to ISO 13485 and audited under the Medical Device Single Audit Program (MDSAP). Our QMS covers design control, supplier qualification, manufacturing, post-market surveillance, vigilance reporting, and complaint handling.
Every implant is serialised. Every production lot is traceable from raw titanium through final sterile packaging. Adverse events and complaints are triaged within one business day and reported to competent authorities under the timelines set by each jurisdiction.
Investor relations
A long-term programme to raise the standard of care after limb loss.
OI is privately held. We engage selectively with strategic investors and partners aligned with the long-term clinical mission of the OPL programme. For investor enquiries, financials under NDA, or strategic partnership conversations, please reach out directly.
Press
Press & media enquiries.
We work with journalists and producers covering medical devices, prosthetic technology, and the lived experience of amputation. Press packs, executive bios, and high-resolution imagery are available on request.
Careers
Work on something that changes the answer to limb loss.
We hire selectively across regulatory affairs, quality, manufacturing engineering, clinical operations, and commercial partnerships — almost always in Sydney. If you would change the answer to limb loss given the chance, write to us.
Legal entity
Osseointegration International Pty Ltd
- ABN
- 15 604 356 676
- Registered office
- Sydney, New South Wales, Australia
- Role
- Legal manufacturer of the OPL osseointegrated prosthetic system
- QMS
- ISO 13485 certified · MDSAP audited
Work with us