Category: Resorbable Bone Materials

Resorbable Bone Materials

Etex Corp.'s bone sub materials get another 510(k)

April 27, 2009 by MassDevice staff

The Food & Drug Administration cleared the Cambridge biotech's orthopedic putty for small-bone repairs.

The Food & Drug Administration cleared Etex Corp.'s orthopedic putty for use in small-bone repairs.

The Cambridge biotech said the federal watchdog agency gave the nod to 1cc and 5cc sizes of its Beta-bsm injectable paste and Gamma-bsm moldable putty, on top of existing clearances for the 5cc and 10cc sizes.

The bone substitute materials are used to make osteo-conductive scaffolds that ape the nanocrystalline structure of human bone. The smaller sizes were developed for hand and foot/ankle surgeries. The products are used to fill voids in bone that the bone doesn't depend on for stability.

Third Stryker Biotech rep cops plea in off-label promotion case

April 15, 2009 by MassDevice staff

Boston's top fed, Michael Sullivan, announces third guilty plea from a former rep for the Hopkinton biotech firm, days before leaving the job.

U.S. Attorney Michael Sullivan is making his last week on the job a busy one.

Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.

FDA spikes wider use of Stryker's OP-1 putty

April 13, 2009 by Brad Perriello

The Food & Drug Administration denied an application by the medical device giant to expand the use of its genetically engineered OP-1 bone-growth putty.

The federal Food & Drug Administration shot down Stryker Corp.'s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.

The watchdog agency's panel found that bias may have influenced subjects in clinical trials for the medical device giant's OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.

Stryker's biotech division is headquartered in Hopkinton.

Stryker Biotech

36 South St

Hopkinton

01748

United States

(508) 416-5200

www.stryker.com

Product(s):

Develops bone morphogenic proteins to treat long-bone non-union breaks

Employees:

285

Established:

1989

Chairman:

Stephen P. MacMillan

President:

Stephen P. MacMillan

CEO:

Stephen P. MacMillan

Management:

Dean H. Bergy, VP, CFO

Jeanne M. Blondia, VP, treasurer

Lonny Carpenter, president-instruments & medical

Andrew Fox-Smith, president-international

Curtis E. Hall, VP, general counsel

Curt Hartman, VP-finance

Stephen Si Johnson, VP, president-MedSurg

James E. Kemler, VP, president-biotech, osteosynthesis & development

Edward B. Lipes, EVP

Eric Lum, VP-Tax

Tony McKinney, VP, CAO

Katherine A. Owen, VP-strategy & investor relations

James B. Praeger, VP, controller

Michael W. Rude, VP-human resources

Tim Scannell, president-spine and endoscopy

Elizabeth A. Staub, VP-regulatory affairs & QA

Bronwen R. Taylor, VP-internal audit & compliance

Thomas R. Winkel, VP, secretary

Flex Biomedical Inc.

258 Harvard St

Ste 319

Brookline

02446

United States

(617) 935-3269

www.flexbio.com

Product(s):

Manufactures an injectable polymer for treating and diagnosing orthopedic diseases and injuries

Employees:

Established:

2007

Federal probe of Stryker ongoing in off-label promotion case

February 27, 2009 by MassDevice staff

Second Stryker sales manager pleads guilty to promoting the combination of a pair of human bone growth products, despite earlier knowledge of problems with the combination

A federal investigation of Hopkinton’s Stryker Biotech is still underway after a second guilty plea by a former Massachusetts sales manager for the Michigan-based Stryker Corp. subsidiary, which develops bone injury repair products, according to news reports.