Product Availability and Regulatory Status
BioPoly is committed to bringing the BioPoly resurfacing products to the United States and other International countries. At present, the BioPoly Great Toe Hemiarthroplasty Implant is FDA cleared for use in the United States. The Partial Resurfacing Knee and Patella Implants are CE marked for use in most international markets and we are seeking approval/clearance for use in the United States.
Clinical Use
- 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 Partial Resurfacing 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.
Intended Use
BioPoly® Great Toe Hemiarthroplasty Implant. Restore the articular surface of the first metatarsal bone
BioPoly® Partial Resurfacing Knee Implant. Cartilage lesion located in the weight-bearing region of medial or lateral femoral condyles or the trochlear facets
BioPoly® Partial Resurfacing Trochlea Implant. Cartilage lesion located in the trochlear groove
BioPoly® Partial Resurfacing Patella Implant. Cartilage lesion located in medial or lateral facets of the patella
Packaging and Sterilization
The BioPoly® implants are provided sterile and for single use.
See Information For Use (IFU) on literature page for more information.