Category: Bone Cements & Microbial Agents

Doctors Research Group wins 510(k) clearance for bone cement

November 18, 2009 by MassDevice staff

Doctors Research Group Inc. won 510(k) clearance from the Food & Drug Administration for its Kryptonite bone cement in cranioplasty procedures.

Details emerge in federal case against Stryker Biotech

October 29, 2009 by MassDevice staff

A federal indictment brought by a Boston grand jury against Stryker Biotech sheds light on the charges against the company and the four managers charged with a two-year campaign to promote the off-label combination of two bone growth products and lying to the FDA.

Stryker Biotech, former president, sales managers charged in federal beef

October 28, 2009 by MassDevice staff

Stryker Biotech, its former president and three current sales managers were slapped with federal charges of promoting the off-label use of a pair of bone-growth products and lying to the Food & Drug Administration.

The Hopkinton, Mass.-based firm and its former president, Mark Philip, along with sales managers David Ard, Jeff Whitaker and William Heppner, were indicted by a grand jury on charges of wire fraud and conspiracy. Stryker and Philip were also charged with making false statements to the FDA.

Medical device maker faces federal rap for unauthorized clinical trials

June 18, 2009 by MassDevice staff

Synthes Inc. and four former executives face federal charges accusing them of conducting unapproved clinical trials, according to the U.S. Justice Dept.

Synthes subsidiary Norian Corp. faces 52 felony counts, including conspiracy to obstruct the Food & Drug Administration and "to commit crimes against the United States," according to a Justice Dept. release. The company was also slapped with seven counts of making false statements in an FDA investigation and 44 counts of releasing "adulterated and misbranded" shipments of its Norian XR cement "with intent to defraud."