April 18, 2017 – PaxMed proudly announces the FDA 510(k) clearance of NovoGro moldable bone substitute putty, on behalf of its manufacturer, OsteoNovus, of Toledo, Ohio. NovoGro Putty is a breakthrough bone regeneration biomaterial with excellent handling properties. It is intended for use as a bone void filler for gaps and voids that are not intrinsic to the stability of the bony structure. NovoGro Putty is intended to be hydrated with sterile water and gently packed into bony voids or gaps of the skeletal system, i.e., extremities and pelvis.
The 510(k) submission was supported by animal studies using a rabbit critically sized cancellous defect model, conducted at the Surgical and Orthopaedic Research Laboratories, University of New South Wales, Randwick (Sydney), Australia, under the direction of Dr. W. R. Walsh of UNSW, with contributions by Dr. Brian Schlossberg of OsteoNovus and Dr. Kevin Thomas of PaxMed.
This clearance marks the 193rd 510(k) clearance received by PaxMed on behalf of its clients, as well as the 44th clearance for Dr. Thomas, PaxMed’s Vice President and Director of Regulatory Affairs.