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OsteoZapTM is designed to prevent infection and biofilm formation on orthopaedic implants such as hips and knees, trauma devices, and spinal and dental implants by combining long-term infection prevention and anti-colonization functionality with the osteointegration benefits of EnBIO’s OsteoZip surfaces. OsteoZap is an apatitic/bioceramic surface optimized to be antimicrobial. It can be applied to all types of orthopaedic implant surfaces, from bare metal to surfaces which already have a mechanically optimized morphology, i.e., 2D surfaces (grit-blasted, titanium sputtered) and 3D surfaces (sintered bead, metal foam, SLM).
Importantly, EnBIO has identified a 510K regulatory approval pathway which does not require clinical trials prior to market launch. A FDA PMN -510(k) designate masterfile is currently being prepared. EnBIO is presently performing extensive analysis to characterize these surfaces. Contact us for more information.
More information on OsteoZap is contained in the Datasheet.
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Advantages
- Stepping stone technology (HA > Antimicrobial > Drug Eluting)
- Infection preventing surface combined with optimal osteointegration
- FDA pathway which does not require clinical trials
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