The FDA has given DePuy Orthopaedics, a Johnson & Johnson unit, supplemental premarket approval for its Trumatch Personalized Solutions software. The technology, which will be used with the company's Sigma RP knee implant already approved by the FDA, will allow doctors to customize the implant according to each patient's physiology.
DePuy Orthopaedics, a unit of Johnson & Johnson, has received supplemental premarket approval from the FDA for a 36-millimeter version of its Ceramax Ceramic Total Hip System. The implantable device was first approved in 2010 for noncemented use in adult patients receiving total hip replacements.
The FDA has granted premarket approval to DePuy Orthopaedics, a Johnson & Johnson unit, for use of its AOX antioxidant polyethylene material in knee systems. The material, which will be used in combination with the company's Sigma and LCS Complete knee replacement systems, aims to enhance the long-term oxidative stability and wear resistance of the devices.
OrthoWorx, an initiative that seeks to expand the orthopedics industry in Indiana, has appointed David Floyd as CEO. Floyd in March resigned from his position as CEO of DePuy Orthopaedics, a Johnson & Johnson unit, amid the recall of the company's ASR hip replacement system.
The FDA has granted DePuy Orthopaedics, a subsidiary of Johnson & Johnson, 510(k) clearance to market its TruMatch system, designed to give a customized fit to patients undergoing knee replacement surgery. The device is used in combination with the company's Sigma fixed-bearing knee implant.