IFU · Transfemoral
Resources
The documents clinicians, partners, and funders ask for — in one place.
Instructions for Use, surgical technique guides, clinical protocols, MR safety annexes, funding guidelines, and the OPL citation index. Most documents are released to verified recipients on request.
Instructions for Use
IFUs and surgical technique guides.
Released to verified clinicians, certified partners, and notified-body auditors. Submit a request and our regulatory team will respond within one business day.
IFU · Transtibial
OPL transtibial Instructions for Use
IFU · Transhumeral
OPL transhumeral Instructions for Use
Surgical technique
OPL single-stage surgical technique guide
Component catalogue
OPL component reference catalogue
Clinical guidelines & protocols
Pre-operative, surgical, and rehabilitation protocols.
The OPL clinical pathway has been refined over two decades of clinical practice. Released to certified centres and clinicians enrolled in OPL training.
Protocol · Patient selection
OPL pre-operative patient selection criteria
Protocol · Single-stage
Single-stage osseointegration surgical protocol
Protocol · Rehabilitation
Post-operative rehabilitation pathway
Protocol · Stoma care
Long-term stoma care guidance
MR safety
MR Conditional under defined conditions.
The OPL implant system has been evaluated for use in the magnetic resonance environment and is labelled MR Conditional. Scanning is permitted under the field strength, gradient, RF, and SAR conditions specified in the IFU.
Full MR Conditional labelling, image artefact characterisation, and scanning parameters are documented in the device IFU and supplementary MR safety annex. Both are released to clinicians and radiology departments via the document request workflow above.
Funding guidelines
Reimbursement and funding pathways by jurisdiction.
Funding for osseointegration varies by country and payer. The summaries below describe the principal pathways our clinical partners work with. For jurisdiction-specific guidance — or to request a funding submission template — contact our team.
Australia
NDIS & private health
Funded under NDIS assistive technology and selected private health insurers. Submission templates available to certified centres.
United Kingdom
NHS individual funding
Individual Funding Request (IFR) pathway through the patient’s ICB. Self-pay and military covenant routes also operate.
European Union
National schemes vary
Coverage is jurisdiction-specific. Several national schemes reimburse osseointegration for selected indications. Contact us for country-specific guidance.
Self-funded
International & private
Many international patients are treated on a self-funded basis. Indicative all-inclusive pathway costs available on request.
Evidence base
290+ peer-reviewed studies.
Osseointegration is one of the most rigorously studied advances in prosthetic reconstruction of the last three decades — covering safety, function, gait, quality of life, and long-term outcomes. Our citation index covers the principal studies on OPL and the underlying technique.
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