ConforMIS, Inc. manufactures a line of 3-D printed total and partial knee replacement products, including the:
All of these ConforMIS knee devices are delivered to hospitals with a complete set of pre-sterilized instrumentation that has been customized for each patient using CT scan data. In August 2015, ConforMIS recalled hundreds of these customized sets after it had received three reports of moisture on the instrumentation.
ConforMIS, Inc. uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped to fit each patient’s anatomy. Its line of implants is available in the United States, Germany and the United Kingdom. More than 30,000 ConforMIS knee device have been sold in the U.S. and Europe.
The iUni Knee Replacement System is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. It unicompartmental design preserves parts of the knee parts not damaged by arthritis. The system is indicated for:
ConforMIS touts the iDuo partial knee system as an alternative to traditional total knee replacement. Designed to mimic the natural shape of the knee, the iDuo line consists of:
iDuo implants are indicated for restoring joint function and relief of pain due to:
The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments. It’s indications for use include:
The iTotal PS, which addresses the largest segment of the knee replacement market, was launched on a limited basis in February 2015. ConforMIS expects to expand its launch in 2016. The iTotal PS is the only posterior cruciate ligament substituting, customized total knee replacement product on the market.
On August 31, 2015, ConforMIS announced that it had initiated a voluntary recall for 950 patient-specific instrumentation sets used with the iUni, iDuo, iTotal CR and iTotal PS systems, following complaints of moisture on the instrumentation. The U.S. Food & Drug Administration (FDA) granted the recall Class II status, which indicates that a medical device has the potential to cause temporary or reversible health consequences.
Of the instrumentation sets recalled, 650 had already been used in knee implant surgeries. ConforMIS was seeking the return of approximately 300 unused knee replacement product systems, which include the patient-specific instrumentation sets. According to the company, the instrumentation included in the ConforMIS knee recall may have held excess water before undergoing the commonly used ethylene oxide sterilization process and, as a result, may contain small amounts of ethylene glycol residue. Read More
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