Biomedical Raw Materials
Premium PEKK polymer solutions for the medical device industry
Traditionally, medical devices have been made with metallic compounds such as stainless steel or titanium. Today, biocompatible high performance thermoplastics such as our OXPEKK®-MG (Medical Grade) and OXPEKK®-IG (Implant Grade) products offer several advantages over metals in terms of process flexibility, reduced weight, non-corroding, and tailored formulations to meet biomechanical and design criteria.
General characteristics of OXPEKK® biomedical polymers include:
- Density similar to bone
- Stiffness similar to bone
- Excellent abrasion resistance
- Minimization of detrimental stress shielding
- Compatibility with most common sterilization methods
- Twice the compressive strength of PEEK
- Chemically inert & non-absorbable
- Successful 52-week biocompatibility testing to ISO 10993 for our OXPEKK®-IG grade
Our OXPEKK®-IG materials are designed to meet the United States FDA and the European Union normative requirements for use in Long Term Human Implantable Medical Devices. OXPEKK®-IG has been tested according to ISO 10993. The biocompatibility test data and exhaustive analytical extraction studies are included in our restricted FDA Master File. With its ultimate purity and inherent mechanical and structural properties, OXPEKK®-IG has rapidly become an enabling biomaterial for the fast-growing orthopedic and reconstructive surgery industries.
In 2013, OPM received its first 510(k) for the OsteoFabTM Patient Specific Cranial Device, a 3-D printed device made from OXPEKK®-IG.
OPM's South Windsor facility is certified to ISO 9001 and ISO 13485 quality systems and 100% dimensional inspection certification.
OXPEKK® Pellets are available in filled and unfilled grades of different viscosities and structures.
To supplement our offerings of unfilled OXPEKK® material, we have also strived to develop composite materials to provide our customers even more versatile products.
Compared to PEEK, our composite materials have:
- Improved adhesion to fillers
- Easier molding and processibility with fillers
- Lower processing temperatures
- Improved mechanical properties
Titanium dioxide-filled OXPEKK®-MG200 and –IG200 Pellet
OPM offers OXPEKK® Rods with diameters ranging from 8mm to 50mm.
Films & Fibers
Combining our OXPEKK®-IG material with carbon fibers, OXPEKK® BioFlex™ is available in cross- or torsion- ply (.pdf)