DePuy Synthes gets additional FDA clearance for spine systems in adolescent scoliosis surgery

DePuy Synthes Viper2

Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes Spine is expanding its reach in the spine market with U.S. Food and Drug Administration clearance of three of its systems for use in adolescents with scoliosis undergoing posterior noncervical pedicle screw fixation.

The Expedium, Viper and Viper 2 spine systems, which are already cleared for use in adults, received the additional 510(k) clearance last month, the company said today. The Viper and Viper 2 have been used in minimally invasive spine surgeries since 2005 and 2008, respectively, and the Expedium 4.5 Spine System for use in small statue patients was launched in 2008.

An estimated 30,000 children with adolescent idiopathic scoliosis are fitted with a brace each year, according to the National Scoliosis Foundation. Those with a spine curvature that exceeds 45 degrees may be recommended for spinal fusion surgery, in which pedicle screws are often used in conjunction with autograft or allograft to affix rods to the spine.


J&J’s competitor Medtronic (NYSE:MDT) was first to receive FDA clearance of a pedicle screw system to treat adolescent idiopathic scoliosis in December of 2010 and also received clearance for its TSRH Spinal System for use in adolescents in September of last year. But DePuy Synthes has previously addressed the adolescent spine market with a saliva-based genetic test, ScoliScore, developed by Axial Biotech to predict the risk of curve progression in children ages 9 through 13 diagnosed with AIS.

DePuy, which generated sales of $5.8 billion in 2011, acquired skeletal fixation company Synthes Inc. for $19.7 billion in April of last year.

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