SITES Medical offers a complete, concept-to-launch R&D capability, available to orthopedic OEM’s as well as inventors and entrepreneurs. It’s one-stop shopping – but we can also do any one part of this if you prefer. We work with your clinical team or we can assemble one using our network. We’re flexible. And we are ISO 13485 certified.

With the fast-moving migration of procedures from the in-patient hospital setting to the ASC where clinicians prioritize products offering cost and efficiency advantages, OEMs need to respond quickly to these evolving needs. Our deep industry knowledge ensures a quick grasp of a problem and our extensive experience helps us avoid pitfalls, ensuring the swiftest possible project execution. Collectively, our team has experience across every orthopedic sub-specialty – large and small joint reconstruction, spine, sports medicine, trauma, extremities and veterinary – as well as dental surgery. We are ASC-Ready™

Sample R&D projects

OsteoSync™ Ti Platform Technology

This was a complete, in-house, concept-to-commercial partnership initiative culminating in the regulatory approval of our high performance, yet cost-effective porous metal ingrowth material and commercial partnerships for definitive products that incorporate it.

Specific activities included:

  • Concept Development
  • IP Development & Management
  • Prototyping
  • Testing & Research
  • Process Validation
  • Manufacturing Scale-up
  • Regulatory Master File Development
  • Commercial Partnership Development

OsteoSync™ Ti IBF Spine Device

This project was conducted together with a client partner whereby SITES developed the initial OsteoSync Ti/PEEK bonding process and the rest of the detailed product development was performed in conjunction with the partner. The resulting product facilitates initial and long-term stability with the OsteoSync technology with negligible wear debris on insertion and the PEEK material enables visualization of fusion. This product is currently enjoying clinical and commercial success under the tradename FortiCore®.

Specific activities included:

  • Concept Development
  • Design With User Input
  • Prototyping
  • Testing
  • Process Validation
  • Manufacturing Scale-up
  • Regulatory Master File Development
  • Supported Regulatory Approval

OsteoSync™ Ti Knee Components

This project was conducted with a client partner with the initial OsteoSync Ti/Ti and OsteoSync Ti/CoCr bonding process development completed by SITES and the rest of the detailed product development done in conjunction with the partner. The OsteoSync material facilitates initial and long-term implant stability.

Specific activities included:

  • Concept Development
  • Design With User Input
  • Prototyping
  • Testing
  • Process Validation
  • Manufacturing Scale-up
  • Regulatory Master File Development
  • Supported Regulatory Approval

OsteoSync™ Ti Foot Reconstruction Wedges

This project was conducted with a client partner using SITES’ proprietary OsteoSync Ti material and the detailed development was performed to the client’s specifications. The OsteoSync material facilitates initial and long-term stability. This detailed development was launched in 2016 to a highly receptive customer base under the tradename BioSync® Anatomic Reconstruction Wedge.

Specific activities included:

  • Concept Development
  • Prototyping
  • Testing
  • Manufacturing
  • Regulatory Master File Development

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