Product Availability and Regulatory Status
BioPoly is committed to bringing the BioPoly resurfacing products to the United States and other International countries. At present, these devices are CE marked for use in most international markets and we are seeking approval/clearance for use in the United States. BioPoly is not yet available in the United States.
- Patients are receiving the BioPoly implants throughout Europe and parts of Asia.
- Patients are part of a multi-center post-market registry study for the BioPoly RS Knee Implant. The study has been fully enrolled. Click here to learn more.
- Patients are being enrolled in a multi-centre post-market registry study for the BioPoly Patella Implant. Click here to learn more.
- A BioPoly Knee and Patella specific pathway has been launched on Amplitude to allow clinicians to collect clinical outcomes from their patients. Instructions for using the pathway can be found in the Amplitude Pro One User Guide.
BioPoly® RS Knee. Cartilage lesion located in the weight-bearing region of medial or lateral femoral condyles or the trochlear facets
BioPoly® RS Trochlea. Cartilage lesion located in the trochlear groove
BioPoly® RS Patella. Cartilage lesion located in medial or lateral facets of the patella
BioPoly® RS Shoulder. Cartilage lesion located in the humeral head
Packaging and Sterilization
The BioPoly® RS Partial Resurfacing implants are provided sterile and for single use.
See Information For Use (IFU) on literature page for more information.