Press Releases

Further milestone for JUVORA dental disc: US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics

Further milestone for JUVORA dental disc: US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics

High performance polymer dental prosthetic device can potentially enable improved patient quality of life1 and efficiencies compared to metal. Thornton Cleveleys (UK), March 22, 2017 – A major innovation in dental prosthetics for comfort, durability and precision, the JUVORA™ dental disc, has received the US Food and Drug Administration 510(k) clearance for expanded indications. Indications for use in the United [...]

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Invibio Spinal Rods

Invibio: FDA reclassified semi-rigid spinal stabilization systems providing new possibilities for treating patients

Invibio: FDA reclassified semi-rigid spinal stabilization systems providing new possibilities for treating patients

Thornton Cleveleys (UK),  March 8, 2017 – The US Food and Drug Administration (FDA) has recently reclassified semi-rigid spinal stabilization systems from Class III to Class II (*) offering a regulatory pathway to 510(k) clearance in the United States for innovative devices using PEEK-OPTIMA™ polymer based rods from Invibio Biomaterial Solutions ("Invibio"). When compared to rigid systems, semi-rigid PEEK-OPTIMA rods [...]

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Solid Lumbar fusion at 6 months on CT scan with the EVOS-HA Lumbar Interbody System from Cutting Edge Spine.  Image courtesy of Timothy Bassett, MD.

Interbody-fusion outcomes may be improved by use of Invibio’s PEEK-OPTIMA™ HA Enhanced polymer

Interbody-fusion outcomes may be improved by use of Invibio’s PEEK-OPTIMA™ HA Enhanced polymer

Thornton Cleveleys (UK), January 17, 2017 – Early clinical results presented by surgeons at the 2016 annual meeting of the North American Spine Society (NASS)1 demonstrate high fusion rates at 6 months and beneficial clinical outcomes, for patients in the majority of cases, when PEEK-OPTIMA™ HA Enhanced is used for interbody-fusion devices. The implantable high-performance polymer, from Invibio Biomaterial Solutions, [...]

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Invibio and Maxx Orthopedics collaborate on knee-replacement technology

Invibio and Maxx Orthopedics collaborate on knee-replacement technology

Thornton Cleveleys (UK) – Invibio Knee Ltd, a subsidiary of Invibio Biomaterial Solutions has partnered with Maxx Orthopedics, Inc. to develop a PEEK-OPTIMA™ femoral knee1 replacement. The technology is being developed to address some of the unmet needs of more than half a million patients2 annually who are not satisfied with their outcome after total knee arthroplasty using metal-based knee solutions. An [...]

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Invibio PEEK-OPTIMA™ HA Enhanced

New high-performance biocompatible polymer, PEEK-OPTIMA™ HA Enhanced, soon to be available in China for spinal fusion implants

New high-performance biocompatible polymer, PEEK-OPTIMA™ HA Enhanced, soon to be available in China for spinal fusion implants

Thornton Cleveleys (UK) – An innovative high-performance polymer for spinal fusion implants, PEEK-OPTIMA™ HA Enhanced, which enables early and direct bone apposition, has now passed biocompatibility testing in China.1 This paves the way for approval by the China Food and Drug Administration (CFDA) and local legal compliance, as confirmed in the Regulatory Affairs (RA) clearance process. In Europe and the [...]

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