Category: Knees

FDA warns Biomet on knee replacement planning system

August 17, 2010 by MassDevice staff

The Food & Drug Administration warned Biomet Inc. that its personalized knee implant planning offering, the Signature Personalized Patient Care system, lacks approval or clearance to be on the market in the U.S.

In a July 27 warning letter, the FDA warns the Warsaw, Ind.-based firm that the system, which uses MRI and CT scans to develop a pre-operative plan for implanting Biomet's Vanguard knee replacement, does not have pre-market approval, an investigational device exemption or 510(k) clearance from the watchdog agency.

Balky hip sales giving Smith & Nephew trouble in the U.S. market

August 6, 2010 by MassDevice staff

Smith & Nephew PLC (NYSE:SNN) is experiencing some hip problems, but it has nothing to do with the 154 year old company's age.

The British orthopedics giant said soft sales of its hip products contributed to shrinking sales in the U.S. market as the recession continues to push people towards delaying elective orthopedic surgical procedures, according to company CEO David Illingworth.

For the three month period ended July 3, the company posted a $137 million profit on $959 million in sales, a 16 percent jump from the $118 million profit on $926 million in sales for the same period last year.

Histogenics launches clinical trial

July 9, 2010 by MassDevice staff

Histogenics Corp. launched a Phase III clinical trial of its NeoCart knee cartilage repair implant, designed to help regenerate tissue.

The Waltham, Mass.-based company said the 245-patient study will compare use of the implant with standard microfracture surgery to repair damaged knee cartilage. Microfrature surgery involves drilling small holes in bone to fill the defect with blood clots. The NeoCart device uses neocartilagenous tissue developed from patients' chondrocyte cells, which are integrated into a three-dimensional collagen matrix, according to a press release.

ProChon Biotech inks another contract manufacturing pact

June 21, 2010 by MassDevice staff

ProChon Biotech Ltd. entered into a contract manufacturing agreement with Mississauga, Ontario-based therapeutic protein developer Therapure Biopharma.

The deal is the latest in the Woburn, Mass.-based company's build-out for its manufacturing infrastructure. ProChon is developing tissue regeneration technology for articular cartilage injuries of the knee and, eventually, other joints.

ProChon Biotech taps new regulatory VP

June 8, 2010 by MassDevice staff

ProChon Biotech Ltd. hired of Brian Callahan for the role of executive vice president, regulatory and quality affairs.

Callahan's last job was with EEC & Associates, a global compliance consulting firm for the medical device and pharmaceutical industries. At Prochon he'll be the company's liaison to regulatory agencies, including the Food & Drug Administration, European Medical Authorities and Israeli Ministry of Health, in addition to overseeing regulatory strategy, implementation and compliance.

Smith & Nephew wins 510(k) clearance for 30-year claim on knee implant

April 22, 2010 by MassDevice staff

Smith & Nephew Inc. (NYSE:SNN) won 510(k) clearance from the Food & Drug Administration for new labeling on its Legion knee implant, which it says can now last up to 30 years.

ConforMIS wins CE Mark for next-gen custom knee implant

April 13, 2010 by MassDevice staff

ConforMIS Inc. won CE Mark approval in the European Union for the next generation of one of its custom knee implants, the iUni G2.