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Product Overview

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surface modification

Products > Antimicrobial Surface: OsteoZapTM

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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.

 

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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