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 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.

Our OXPEKK-MG® and –IG® products have had thousands of successful implantations and have been used in devices cleared for medical and implantable use by the FDA, KFDA, ANVISA, COFEPRIS, and a number of CE-Marked devices.

OPM's South Windsor facility is certified to ISO 13485 and ISO 9001 quality systems.           

OXPEKK® pellets are available in filled and unfilled grades of different viscosities and structures.

Unfilled:

Amorphous Grade OXPEKK®-MG100 and -IG100 pellet (.pdf)

Crystalline Injection Grade OXPEKK®-MG200 and -IG200 pellet (.pdf)

Composites:

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

Carbon-filled OXPEKK®-MG200 and –IG200 pellet (.pdf)

Barium sulfate-filled OXPEKK®-MG and –IG pellet (.pdf)

Titanium dioxide-filled OXPEKK®-MG200 and –IG200 pellet

OPM offers OXPEKK® rods with diameters ranging from 8mm to 50mm.

Crystalline Extrusion Grade OXPEKK® -MG300 and -IG300 Rod (.pdf)

Barium sulfate-filled OXPEKK®-MG300 and –IG300 Rod (.pdf)

Monofilament (.pdf)

Multifilament (.pdf)

Permetta™ Films (.pdf)

Combining our OXPEKK®-IG material with carbon fibers, OXPEKK® BioFlex™ is available in cross- or torsion- ply (.pdf)