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.
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OXPEKK®-IG is our Implantable Grade Polymer that is used for ALL applications (implant and certain non-implant applications) that require the following:
- Full biocompatibility certification
- Access to OPM's FDA Master File for US submissions
- Access to biocompatibility testing for non-US customers
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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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.
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Table of Properties - OXPEKK® Medical and Implant Grades - View the Table
Typical properties of Cortical Bone and Selected Biomaterials
– lower than metallic biomaterials and similar to human bone – are extremely desirable from a biomechanical approach.
Most metallic biomaterials have a significantly higher density (2 to 4 times the weight) and are much stiffer (5 to 10 times the modulus) than human bone. Too much stiffness and weight tend to create undesirable conditions leading to negative stress shielding, bone resorbtion and atrophy.
On the contrary, the “lighter” weight of OXPEKK®-IG combined with “bone-like” mechanical properties (elastic modulus, flexural strength, etc.) and excellent compressive strength, results in an implantable device with better force distribution for improved bone-implant interface and higher fusion rate.
For more information on our OXPEKK®-IG products, please email us at oxpekk-ig@oxfordpm.com
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