COMPANY PROFILE
OUR
BUSINESS MODEL: SIMPLE AND FLEXIBLE
It is our commitment to provide premium biomaterials solutions to our
customers. We will do so in a simple and flexible manner that builds mutual
trust and respect.
Simple – One contract, multiple opportunities.
Flexible – Customer Focused Supply Option. Depending on your needs, your
internal capacity, the stage of your project (prototype, commercial device,
etc.), or the size of your device, with OXPEKK®-IG you have the choice of
purchasing:
Injection moldable pellets (OXPEKK®-IG200) and extruded rods (OXPEKK®-IG300)
in a broad range of sizes directly from OPM.
Finished parts directly from our Approved Medical Processing Partners.
Premium Biomaterials
Solutions for the Medical Device Industry
OXPEKK® FOR MEDICAL DEVICES
Traditionally, medical devices have been made with metallic compounds such as
stainless steel or titanium. Today, bio-compatible high performance
thermoplastics such as OXPEKK®-MG (Medical Grade) and OXPEKK®-IG (Implant Grade)
offer several advantages over metals in terms of process flexibility, reduced
weight, non-corroding, and tailored formulations to meet biomechanical and
design criteria, for the following applications:
° Anesthesia Equipment
° Catheters & Drug Delivery
° Sterilization & Analytical Equipment
° Short & Long Term Implantable Devices
Our OXPEKK®-IG material is 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.
OXPEKK®-MG
is our Medical Grade Polymer that:
Is certified to the same manufacturing process as OXPEKK®-IG
Is tested for cytotoxicity
Is restricted to non-implant applications
Has no Master File access and no biocompatibility certification
General characteristics of OXPEKK® biopolymers include:
° Radiolucence
° Density similar to bone
° Stiffness similar to bone
° Excellent abrasion resistance
° Minimize detrimental stress shielding
° Compatible with all sterilization methods
° Twice the compressive strength of PEEK™
° Chemically inert & non-absorbable polymer
° Successful 52-week biocompatibility testing to ISO 10993 for our
OXPEKK®-IG grade
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