Patients.
Introduction.
If you’ve landed on this part of the OSSIS website, we assume you have (or someone you know has) been offered an OSSIS implant and you’re looking for information about our implants and the pros and cons of receiving one.
OSSIS implants are designed and manufactured to high quality processes and procedures, in accordance with ISO 13485.
Prescribing surgeons can provide all the expert advice patients need to make an informed decision, but we are also pleased to provide information about OSSIS implants.
Our Blog page also contains articles that might be of interest, including this patient case study:
https://www.ossis.com/blog/ossis-patient-case-study-roy
and a story about a female orthopaedic surgeon using one of our custom implants for the very first time:
https://www.ossis.com/blog/in-male-dominated-orthopedics-women-are-making-a-difference-ossis
If you are a patient and after reading this page you still have questions or concerns, then please ask your surgeon for more information.
About the OSSIS custom implant
OSSIS manufacture custom implants to assist surgeons in the treatment of patients in unique clinical situations that typically cannot be treated with standard-line products. If you are receiving a custom titanium implant from OSSIS, your implant has been manufactured in accordance with the written prescription of the surgeon for the sole use of you, the prescribed patient.
OSSIS can provide the following custom implants:
1001 – AceOs™
1002 – AceOs™ Plus
1003 – Hemi-Pelvis
1004 – Sacrum
1008 – Custom shoulder
1009 – Spinal implant
1024 – Custom talus implant
1027 – Custom foot and ankle
1028 – Sacroiliac
Please refer to your Patient Implant Card (which each patient receives following their surgery) or ask your surgeon if you have any questions around the kind of device.
Intended purpose for your implant
OSSIS custom implants are intended for use in patients who require reconstruction of the bony anatomy due to disease, deformity, trauma, or revisions due to previously failed surgeries, to reduce or relieve pain and/or improve joint function in skeletally mature patients.
These custom implants are for single use only and by prescription of a medical practitioner. They are typically designed where a standard commercially available implant cannot be used for treatment.
What are the benefits
OSSIS custom implants can provide many benefits including pain reduction and increased mobility.
Undesirable side effects
While undesirable side effects are rare, if you do experience any side effects please consult your prescribing physician for appropriate actions. Some possible side effects that may occur related to your custom implant are:
Premature loss of fixation
Soft tissue irritation and/or nerve damage
Premature implant wear
Premature failure of component due to abnormal loadings or activity
Bone loss around the implant
Numbing or loss of sensation
Joint dislocation
Joint pain or stiffness
Loss of joint mobility
Allergic reaction to the implant’s material
Warnings and precautions
OSSIS custom implants are designed to be exclusively used by the prescribing physician and specifically for the sole use of the prescribed patient.
There are inherent risks associated with the use of implants in a magnetic resonance (MR) environment. These include implant migration, heat induction, or image distortion. The implant has not been tested for safety and compatibility in an MRI environment; you are advised to present your Patient Implant Card or notify your prescribing physician of your implant prior to any MRI examination.
The implant may activate metal detectors.
There are no known residual risks that could arise due to any shortcomings of the protection measures adopted. You should follow any precautions presented to you post-operatively by your surgeon.
If the performance of the device changes, please contact your surgeon.
Expected device lifetime
OSSIS has a “One implant for life” philosophy. However, as each device is custom made, the lifetime of OSSIS devices are dependent on each patient’s anatomy and pathology at the time of operation and following the operation. It is recommended patients talk with their physician for further guidance.
Your prescribing physician must inform you of anything that could shorten or lengthen your custom implant’s lifetime. These include precautions to take in your daily life, as your activity level and weight can affect the lifetime of any orthopaedic implant.
Please contact your surgeon if you experience any changes to your custom implant’s performance.
Monitoring and maintenance
A recommended rehabilitation program will be implemented and catered specifically for you and your custom implant by the prescribing surgeon. The implant does not require maintenance; however regular post-operative follow-ups are recommended to monitor your custom implant and detect any early signs of wear or loosening.
Please confer with your prescribing physician for a recommended post-operative follow-up schedule. Following a regular post-operative schedule can provide guidance at or near the end of the expected device lifetime.
If you experience any side effects, please contact your prescribing physician to determine the appropriate action to be taken.
Materials and substances in the device
The OSSIS custom implant is 3D printed in a titanium alloy (Ti6Al4V).
Some OSSIS custom implants, at the prescribing surgeon’s request, are coated with HyProtect™, an antimicrobial ultra-thin plasma coating. HyProtect™ is a combination of pure silver and polysiloxane.
Please refer to your patient implant card or ask your prescribing surgeon if you have any questions around the kind of device you have been prescribed.
Manufacturing residues
OSSIS custom implants are cleaned and packaged using a proven validated process to ensure the appropriate residues from the manufacturing process are removed.
What to do if a serious incident occurs involving your device
Any issues relating to the quality of the OSSIS product, its identity, durability, reliability, safety, effectiveness and/or its performance, should be reported to OSSIS.
If the implant has malfunctioned, or is suspected of having malfunctioned, please notify your physician immediately.
“In urgent oncology cases, the speed and durability of OSSIS custom implants has enabled life-changing results for patients.”
Any serious incident that occurs in relation to your implant should be reported to both OSSIS and the regulating authority where you received your implant:
European Union
Medical Device Regulation (MDR)
Report to EU competent authority of the member state where you received your custom device
New Zealand
MedSafe
United Kingdom
Medical and Healthcare products Regulatory Agency (MHRA)
United States
Food and Drug Administration (FDA)
Many thanks for your interest in OSSIS implants.
We specialise in finding solutions to complex problems, with a robust product and a rapid process that puts OSSIS well ahead of traditional solutions and competing providers. Surgeons using a patient-specific implant from OSSIS, crafted with a combination of clinical and engineering expertise as well as in-depth anatomical knowledge, avoid the issues that can arise with off-the-shelf options.
For tumour cases, there can sometimes be no alternative other than 3D printed implants. Tumours grow quickly, and OSSIS can provide a solution to the surgeon rapidly.
Every OSSIS implant is designed to be used exclusively by the prescribing physician and specifically for the sole use of the prescribed patient. Surgeons using OSSIS implants can offer patients an improved quality of life, even when facing a complicated diagnosis.
Please download our Patient Information leaflet for your further reference.
“In urgent oncology cases, the speed and durability of OSSIS custom implants has enabled life-changing results for patients.”