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U.S. Department of Health and Human Services

Product Classification

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Device filler, bone void, recombinant platelet-derived growth factor
Definition For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.
Physical State The product consists of 1.5, 3, 6, or 9 cc of beta-tricalcium phosphate in granule form and 1.5, 3, 6, or 9 ml of rhPDGF-BB (0.3 mg/ml) in liquid form. The two components are mixed in equal volumes prior to use.
Technical Method The platelet-derived growth factor component is intended to function as a chemo-attractant and mitogen for cells that stimulate the repair and growth of new bone. The osteoconductive calcium phosphate component is intended to act as a scaffold for new bone growth.
Target Area The product is utilized in the hindfoot and ankle for fusion procedures that include tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.
Review Panel Physical Medicine
Product CodeOYR
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible