Intended for the replacement of symptomatic abnormal or severely abnormal (ICRS Grade 2, 3 or 4) chondral or osteochondral focal lesions located in the weight-bearing regions of femoral condyles and trochlear facets.
Lesion size should not exceed 3.1 cm² and must be circumscribed by a 1.5 or 2.0 cm circle or 1.5 by 2.4 cm oval of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall cartilage depth less than 4 mm from the articulating surface. Subchondral bone quality must be deemed sufficient to secure the implant.
Patients with knee pain who are too young for a TKR who want to regain an active lifestyle. They must be over 21 years of age. In addition to being the primary treatment of focal chondral or osteochondral lesions, BioPoly® can also be used in patients who have failed debridement, microfracture, OATS, ACI, MACI, or other biologic procedures provided that the subchondral bone is adequate.
The titanium stems (Ti6-4) used in the BioPoly® Great Toe implants and BioPoly® Partial Resurfacing implants (Knee and Trochlea) contain trace amounts of nickel. Please consult a medical professional regarding whether or not the implant is suitable for you.
BioPoly® Partial Resurfacing Patella implants do not have titanium stems, and, therefore, are safe to use in patients with nickel allergies.
BioPoly® is a next-generation orthopaedic biomaterial, combining Hyaluronic Acid (Bio) and ultra-high molecular weight polyethylene (Poly or UHMWPE). This proprietary material is hydrophilic (water attracting) and interacts favorably with native tissues to support anatomical loads. (HA refers to Hyaluronic Acid, NOT Hydroxyapatite.)
The HA is permanently locked in place by crosslinking the HA to itself within the UHMWPE network. Accelerated aging and degradation testing have shown no degradation even beyond 10 years.
BioPoly® is not exposed to gamma irradiation during its manufacturing or sterilization. Therefore, there are no free radicals present and, thus, premature aging due to oxidation does NOT occur. Accelerated aging to beyond 10 years demonstrated this.
The implant stem is made of titanium alloy (Ti 6-4) with a roughened surface finish for optimal bone on-growth. The surface finish is that same as that of hip prostheses that have been implanted for over a decade.
BioPoly® is direct compression molded onto a titanium stem. A series of crossing dove-tail channels within the stem platform provide mechanical locking of the BioPoly® to the stem.
Extensive testing has been performed to ensure that the BioPoly®-stem interface is robust and will handle the anatomical loading.
There are three sizes of implants – 15mm, 20mm and 15x24mm.
Compared to metal, BioPoly® is a very forgiving material, so the need for replicating the exact curvature is not needed. Second look arthroscopies have shown that cartilage tissue grows around and, depending on the depth of the implant, may even grow over the material, creating a smooth articulating surface.
Human clinical radiographic evidence beyond 4 years continues to show no signs of loosening, migration, or radiolucency.
Ethylene Oxide (EtO)
A post-market registry is underway in the UK with follow up at 6-months, 1, 2, 3, 4, and 5-years. Preliminary results show patients returning to pre-injury activity and improved quality of life scores.
A large animal (goat) study was conducted with time points at 3, 6, and 12 months with no indication of implant wear or degradation nor damage to opposing articular cartilage. ISO 10993 Biocompatibility testing was also successfully performed that included in vivo studies in rabbits and mice.
In order to obtain the CE mark, BioPoly® had to go through extensive mechanical testing on the material and implants to demonstrate safety and performance. The implant was subjected to an equivalent of 10-years of fatigue mechanical loading resulting in no sign of damage and no degradation in mechanical properties.
Accelerated aging studies to beyond 10 years were performed as well as degradation (hyaluronidase) testing, resulting in no degradation in material properties nor any degradation of the hyaluronic acid in the implant. The implant is intended to be permanent.
Place the appropriately sized trial instrument over the defect and ensure that the defect is surrounded by cartilage. The implant corresponding to the trial instrument is the proper size.
BioPoly® should be implanted 0.5mm below the surrounding cartilage surface. This will enable the implant to share the load with adjacent cartilage.
Please note: BioPoly® should not be implanted to a depth greater than 2.0mm nor should it ever be implanted proud.
BioPoly® Partial Resurfacing Instruments are designed to reference off of the articulating surface of the patient's anatomy. Drilling until the reamer stops on the appropriately sized reaming cannula will ensure that the proper reaming depth is achieved. To verify the implant site is acceptable, the appropriately sized trial can be inserted into the defect.
BioPoly® implantation can be arthroscopically assisted. In other words, the defect size can be determined and the appropriateness of BioPoly® can be established arthroscopically; however, the defect bed and implantation of the BioPoly® device should be done through a mini-arthrotomy incision.
Yes, BioPoly® Partial Resurfacing Knee implants are indicated for use with bone cement.
Clinical data indicates there are roughly 202,000 cartilage procedures performed annually.
The articular cartilage repair market can be divided into two segments: (a) debridement and microfracture, which is very cost effective; however, these procedures have not proven to be very effective long-term; and (b) those that require an implant. Implants can further be segmented into biologic (i.e., rely on patient’s biology for successful repair tissue, e.g., collagen or polymers) or synthetic implant (metallic and polymer replacement of chondral or osteochondral defects).
Clinical data shows that of the approximately 174,000 debridement and microfracture procedures performed annually, approximately 30% fail after the first 18-months. As a first source of patients, these failures would be good candidates for a BioPoly® implant. If, however, we factor in all 202,000 cartilage procedures, it is estimated that approximately 38% (76,760) could be potential BioPoly® candidates. Actual applicability will depend on defect size and location and on the status of the adjacent cartilage. We intend for BioPoly® to be the standard of care to treat the defects that are currently being microfractured or debrided.
Intended for the replacement of symptomatic abnormal or severely abnormal (ICRS Grade 2, 3, or 4) chondral or osteochondral focal lesions located in the femoral trochlear groove.
Lesion size should not exceed 3.1 cm2 and must be circumscribed by a 1.5 or 2.0 cm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall cartilage depth less than 4 mm from the articulating surface. Subchondral bone quality must be deemed sufficient to secure the implant.
Patients with knee pain who are too young for a TKR who want to regain an active lifestyle. They must be over 21 years of age. In addition to being the primary treatment of focal chondral or osteochondral lesions, BioPoly® can also be used in patients who have failed debridement, microfracture, OATS, ACI, MACI, or other biologic procedures provided that the subchondral bone is adequate.
The titanium stems (Ti6-4) used in the BioPoly® Great Toe implants and BioPoly® Partial Resurfacing implants (Knee and Trochlea) contain trace amounts of nickel. Please consult a medical professional regarding whether or not the implant is suitable for you.
BioPoly® Partial Resurfacing Patella implants do not have titanium stems, and, therefore, are safe to use in patients with nickel allergies.
BioPoly® is a next-generation orthopaedic biomaterial, combining Hyaluronic Acid (Bio) and ultra-high molecular weight polyethylene (Poly or UHMWPE). This proprietary material is hydrophilic (water attracting) and interacts favorably with native tissues to support anatomical loads. (HA refers to Hyaluronic Acid, NOT Hydroxyapatite.)
The HA is permanently locked in place by crosslinking the HA to itself within the UHMWPE network. Accelerated aging and degradation testing have shown no degradation even beyond 10 years.
BioPoly® is not exposed to gamma irradiation during its manufacturing or sterilization. Therefore, there are no free radicals present and, thus, premature aging due to oxidation does NOT occur. Accelerated aging to beyond 10 years demonstrated this.
The implant stem is made of titanium alloy (Ti 6-4) with a roughened surface finish for optimal bone on-growth. The surface finish is that same as that of hip prostheses that have been implanted for over a decade.
BioPoly® is direct compression molded onto a titanium stem. A series of crossing dove-tail channels within the stem platform provide mechanical locking of the BioPoly® to the stem.
Extensive testing has been performed to ensure that the BioPoly®-stem interface is robust and will handle the anatomical loading.
15mm and 20mm diameters that are configured to accommodate trochlear grooves that are standard, shallow or dysplasia anatomies
Compared to metal, BioPoly® is a very forgiving material, so the need for replicating the exact curvature is not needed. Second look arthroscopies have shown that cartilage tissue grows around and, depending on the depth of the implant, may even grow over the material, creating a smooth articulating surface.
Human clinical radiographic evidence beyond 4 years continues to show no signs of loosening, migration, or radiolucency.
Ethylene Oxide (EtO)
With a similar implant (BioPoly® Partial Resurfacing Knee) a post market registry is underway in the UK with follow up at 6-months, 1, 2, 3, 4, and 5-years. Published results show patients returning to pre-injury activity and improved quality of life scores.
A large animal (goat) study was conducted with time points at 3, 6, and 12 months with no indication of implant wear or degradation nor damage to opposing articular cartilage. ISO 10993 Biocompatibility testing was also successfully performed that included in vivo studies in rabbits and mice.
In order to obtain the CE mark, BioPoly® had to go through extensive mechanical testing on the material and implants to demonstrate safety and performance. The implant was subjected to an equivalent of 10-years of fatigue mechanical loading resulting in no sign of damage and no degradation in mechanical properties.
Accelerated aging studies to beyond 10 years were performed as well as degradation (hyaluronidase) testing, resulting in no degradation in material properties nor any degradation of the hyaluronic acid in the implant. The implant is intended to be permanent.
Place the appropriately sized trial instrument over the defect and ensure that the defect is surrounded by cartilage. The implant corresponding to the trial instrument is the proper size.
BioPoly® should be implanted 0.5mm below the surrounding cartilage surface. This will enable the implant to share the load with adjacent cartilage.
Please note: BioPoly® should not be implanted to a depth greater than 2.0mm nor should it ever be implanted proud.
BioPoly® Partial Resurfacing Instruments are designed to reference off of the articulating surface of the patient's anatomy. Drilling until the reamer stops on the appropriately sized reaming cannula will ensure that the proper reaming depth is achieved. To verify the implant site is acceptable, the appropriately sized trial can be inserted into the defect.
BioPoly® implantation can be arthroscopically assisted. In other words, the defect size can be determined and the appropriateness of BioPoly® can be established arthroscopically; however, the defect bed and implantation of the BioPoly® device should be done through a mini-arthrotomy incision.
Yes, BioPoly® Partial Resurfacing Trochlea implants are indicated for use with bone cement.
Clinical data indicates there are roughly 202,000 cartilage procedures performed annually.
The articular cartilage repair market can be divided into two segments: (a) debridement and microfracture, which is very cost effective; however, these procedures have not proven to be very effective long-term; and (b) those that require an implant. Implants can further be segmented into biologic (i.e., rely on patient’s biology for successful repair tissue, e.g., collagen or polymers) or synthetic implant (metallic and polymer replacement of chondral or osteochondral defects).
Clinical data shows that of the approximately 174,000 debridement and microfracture procedures performed annually, approximately 30% fail after the first 18-months. As a first source of patients, these failures would be good candidates for a BioPoly® implant. If, however, we factor in all 202,000 cartilage procedures, it is estimated that approximately 38% (76,760) could be potential BioPoly® candidates. Actual applicability will depend on defect size and location and on the status of the adjacent cartilage. We intend for BioPoly® to be the standard of care to treat the defects that are currently being microfractured or debrided.
Intended for the replacement of symptomatic abnormal or severely abnormal (ICRS Grade 2, 3 or 4) chondral or osteochondral focal lesions located in the medial and/or lateral facet of the patella in patients over 21 years of age.
Lesion size should not exceed 3.1 cm² and must be circumscribed by a 1.5 or 2.0 cm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall cartilage depth less than 4 mm from the articulating surface. Subchondral bone quality must be deemed sufficient to secure the implant.
Patients with knee pain who are too young for an arthroscopy who want to regain active lifestyle. They must be over 21 years of age. In addition to being the primary treatment of focal chondral or osteochondral lesions, BioPoly® can also be used in patients who have failed debridement, microfracture, OATS, ACI, MACI, or other biologic procedures provided that the subchondral bone is adequate.
Yes, nickel allergies are not contraindicated because none of the implant materials contain nickel.
BioPoly® is a next-generation orthopaedic biomaterial, combining Hyaluronic Acid (Bio) and ultra-high molecular weight polyethylene (Poly or UHMWPE). This proprietary material is hydrophilic (water attracting) and interacts favorably with native tissues to support anatomical loads. (HA refers to Hyaluronic Acid, NOT Hydroxyapatite.)
The HA is permanently locked in place by crosslinking the HA to itself within the UHMWPE network. Accelerated aging and degradation testing have shown no degradation even beyond 10 years.
BioPoly® is not exposed to gamma irradiation during its manufacturing or sterilization. Therefore, there are no free radicals present and, thus, premature aging due to oxidation does NOT occur. Accelerated aging to beyond 10 years demonstrated this.
No, the BioPoly® RS Patella Implant is made entirely of BioPoly® material. The implant is manufactured via compression molding and a stem is created using a lathe.
Extensive testing has been performed to ensure that the cemented BioPoly® implant is robust and will handle the anatomical loading.
There are four sizes of implants – diameters 15mm and 20mm, and sizes 0 and 1. The sizes 0 and 1 are differentiated by implant thickness.
Compared to metal, BioPoly® is a very forgiving material, so the need for replicating the exact curvature is not needed. Second look arthroscopies have shown that cartilage tissue grows around and, depending on the depth of the implant, may even grow over the material, creating a smooth articulating surface.
Human clinical radiographic evidence beyond 4 years continues to show no signs of loosening, migration, or radiolucency.
Ethylene Oxide (EtO)
A post-market registry is underway in the UK with follow up at 6-months, 1, 2, 3, 4, and 5-years. Preliminary results show patients returning to pre-injury activity and improved quality of life scores.
A large animal (goat) study was conducted with time points at 3, 6, and 12 months with no indication of implant wear or degradation nor damage to opposing articular cartilage. ISO 10993 Biocompatibility testing was also successfully performed that included in vivo studies in rabbits and mice.
In order to obtain the CE mark, BioPoly® had to go through extensive mechanical testing on the material and implants to demonstrate safety and performance. The implant was subjected to an equivalent of 10-years of fatigue mechanical loading resulting in no sign of damage and no degradation in mechanical properties.
Accelerated aging studies to beyond 10 years were performed as well as degradation (hyaluronidase) testing, resulting in no degradation in material properties nor any degradation of the hyaluronic acid in the implant. The implant is intended to be permanent.
Place the appropriately sized trial instrument over the defect and ensure that the defect is surrounded by cartilage. The implant corresponding to the trial instrument is the proper size. Use the depth probe to measure cartilage thickness to determine if a size 0 or 1 implant should be used.
BioPoly® should be implanted 0.5mm below the surrounding cartilage surface. This will enable the implant to share the load with adjacent cartilage.
Please note: BioPoly® should not be implanted to a depth greater than 2.0mm nor should it ever be implanted proud.
BioPoly® Partial Resurfacing Instruments are designed to reference off of the articulating surface of the patient's anatomy. Drilling until the reamer stops on the appropriately sized reaming cannula will ensure that the proper reaming depth is achieved. To verify the implant site is acceptable, the appropriately sized trial can be inserted into the defect.
BioPoly® implantation can be arthroscopically assisted. In other words, the defect size can be determined and the appropriateness of BioPoly® can be established arthroscopically; however, the defect bed and implantation of the BioPoly® device should be done through a mini-arthrotomy incision.
BioPoly® Partial Resurfacing Patella implants are indicated for use with bone cement.
Clinical data indicates there are roughly 202,000 cartilage procedures performed annually.
The articular cartilage repair market can be divided into two segments: (a) debridement and microfracture, which is very cost effective; however, these procedures have not proven to be very effective long-term; and (b) those that require an implant. Implants can further be segmented into biologic (i.e., rely on patient’s biology for successful repair tissue, e.g., collagen or polymers) or synthetic implant (metallic and polymer replacement of chondral or osteochondral defects).
Clinical data shows that of the approximately 174,000 debridement and microfracture procedures performed annually, approximately 30% fail after the first 18-months. As a first source of patients, these failures would be good candidates for a BioPoly® implant. If, however, we factor in all 202,000 cartilage procedures, it is estimated that approximately 38% (76,760) could be potential BioPoly® candidates. Actual applicability will depend on defect size and location and on the status of the adjacent cartilage. We intend for BioPoly® to be the standard of care to treat the defects that are currently being microfractured or debrided.