PaxMed International announces the FDA 510(k) clearance of Neodent Instrument Kits on behalf of Neodent of Curitiba, Brazil, and 510(k) clearance of NovoGro Putty with a posterolateral spine indication on behalf of OsteoNovus, Inc. of Toledo, Ohio, USA.
Neodent Instrument Kits are intended to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. They require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (tray), and tray lid. The clearance includes two kits in one size and two inner tray configurations.
NovoGro Putty from OsteoNovus is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). NovoGro must be used with autograft as a bone extender in the posterolateral spine. It is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical particles that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite [monetite, CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO3OH)•3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical particles are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft.
The preparation of both submissions was led by Dr. Kevin Thomas and represent his 49th and 50th 510(k) clearances as a member of the PaxMed International team.