Device Master File
In 2016, Praxis submitted a Device Master File to the FDA for their Ti-6Al-4V material to streamline customer product submissions. Guidance from ISO 10993 was utilized to conduct tests; please contact Praxis for more details.
Praxis’ OrthoMIM technology offers design flexibility and cost savings specifically for orthopaedic devices. OrthoMIM combines two of Praxis’ proprietary Titanium Injection Molding technologies to provide innovative, cost-saving solutions for orthopaedic applications. Our high fatigue performance material (TiRx™) is combined with our innovative netshape surfacing technology (3DT™) to provide complex, netshape surfaces on economical implant bodies. These technologies are described below:
TiRx™ – For Load Bearing Applications
• Outstanding Fatigue Performance (RFB >90ksi @ 10M cycles)
• Meets chemical and mechanical requirements of Ti-6Al-4V
• Integrates seamlessly with 3DT™ to Co-Form high performance implant bodies.
3DT™ provides tailorable surfaces for uncemented devices, cemented devices and monoblock devices. It allows you to economically apply netshape textures to challenging surfaces. Surfaces are co-formed with a grade 5 titanium substrate that is designed to eliminate delamination concerns.
3DT™ can be used on:
• Inside surfaces such as femoral knees and monoblock cups
• Compound sections like tibial tray posts that are solid titanium with a porous surface
• Contoured/wrap around surfaces products like femoral stems and acetabular cups
Other Therapeutic speciality areas include:
Products within these speciality areas that can be manufactured by Praxis include:
- • Cataract Surgical Equipment
• Endoscopic Graspers/Tools
• Bone reduction Screws
• Ablation Electrodes
• Housing & Implants (Hearing Devices)
• Fixation technology, suture backing plates/parts
• Vascular ports/Catheter ports
• Implantable components: knee, hip, femoral, spinal, hip stems, tibial trays, femoral stems, acetabular cups
• Orthodontic Brackets and Buccal Tubes