What is ZFUZE™ PEEK Biomaterial?
Formulated from PEEK and ceramic zeolites, ZFUZE™ biomaterial combines the beneficial attributes of PEEK and titanium alloys with clinically proven pro-healing behavior.
It offers PEEK’s well-recognized radiolucency and bone-like modulus and adds osteoconductivity that promotes bone tissue growth. Engineered to provide the added benefit of immunomodulation, the biomaterial’s unique composition promotes a rapid shift from the early pro-inflammatory M1 phase to the pro-healing M2 phenotype within 4-5 days. This transition has been shown to enhance pro-healing immunity and mitigate fibrous encapsulation of implanted devices.
The advanced PEEK composite has the biocompatibility necessary for use as a material for long-term implantable medical devices and is available in the form of machinable stock shapes and as pelletized resin for injection molding.
ZFUZE PEEK Offers Benefits Beyond Natural PEEK and Titanium
Titanium and its alloys have challenged PEEK as the preferred biomaterial for certain applications because of the metal’s osteointegrative properties when implanted. However, its extreme rigidity and its opacity in medical imaging have been drawbacks compared to PEEK.
The ZFUZE formulation consists of zeolite molecules integrated into a PEEK polymer matrix. The unique composite is engineered to bridge the gap between natural PEEK and titanium and provide a combination of benefits that surpasses both traditional materials:
- Bone-like load-bearing modulus that affords biomechanical compatibility and structural integrity (Wolff’s Law).
- Radiolucency for accurate imaging.
- Osteoconductive properties to support bone cell fusion and growth.
- Engineered to facilitate a rapid M1-to-M2 phenotype shift that supports immunomodulation, bone tissue growth, and mitigates fibrous encapsulation.
FDA-Cleared as an Immuno-modulating Biomaterial
ZFUZE PEEK is the first and only FDA-cleared immuno-modulating biomaterial. It has proven its ability to shift macrophages rapidly and predictably from the pro-inflammatory M1 phase to the pro-healing M2 phenotype enabling faster, more effective healing.
Why Was ZFUZE Advanced PEEK Developed?
Historically, PEEK and titanium have been the most commonly specified materials for implantable medical devices. Both have significant benefits for a variety of long-term implants, but there are application areas where each has its shortcomings.
Spinal implants are the most notable example, with osteointegration and biomechanical compatibility with bone as key beneficial factors.
Titanium gained ground initially because of its biocompatibility and osteointegrative properties. However, its far higher rigidity compared to bone could impair healing and create the need for revision surgery. Moreover, its radiopacity as a metal interferes with standard imaging techniques (CT, MRI, CBCT) used to monitor surgical site healing and to survey adjacent structures.
PEEK was introduced as an alternative. The polymer’s most beneficial feature is its bone-like elastic modulus that made it an attractive option to replace titanium. Surgeons also gravitated toward PEEK because of its radiolucency that allows surgeons to better evaluate whether the bone is healthy and healing properly, compared to titanium which can create imaging artifacts.
However, the bioinert and hydrophobic attributes of PEEK also somewhat limit full osseointegration. And while osseointegration is enhanced with titanium, its problems with incompatible biomechanics, revision surgery and imaging remain.
The ZFUZE PEEK composite resin was developed by DiFusion Technologies Therapeutic Biomaterials (Austin, TX) to provide bone-related surgical implants the benefits associated with titanium and natural PEEK, without their limitations. It achieves that by adding osteoconductive properties for bone tissue growth to PEEK’s inherent radiolucency and bone-like modulus.
The properties imparted by the zeolites in ZFUZE biomaterial’s unique composition also support a fast and predictable M1-to-M2 transition, thereby reducing the risk of fibrous encapsulation and accelerating the healing process.
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ZFUZE Advanced PEEK Biocompatibility Documentation
FDA Master File support for MDMs is available with extensive biocompatibility documentation on ZFUZE PEEK Biomaterial including ISO 10993 testing and FDA 510(k) submission data. Genesis can provide access to the test reports and other information MDMs may require.
ZFUZE Advanced PEEK Availability
Stock shapes: Genesis Medical Plastics extrudes ZFUZE Advanced PEEK resin into rod and plate for machining precision implantable components and devices.
- Standard rod diameters from 6mm to 40mm enable machining of a wide range of device dimensions and design configurations.
- Plate is available in standard thicknesses from 6mm to 25mm, and widths from 305mm to 610mm maximum.
- Custom sizes including larger diameter rod and thicker plate are available.
- All products are made to order, with reasonable minimums to support product development.
Pelletized resin: ZFUZE PEEK resin is available in pelletized form for producing devices and components by injection molding. In addition to production quantities, Genesis offers low minimums to support MDMs’ at the project development and testing stages.
FAQ's About ZFUZE PEEK
Can the same ZFUZE PEEK Biomaterial Grade Be Both Injection Molded and Machined?
- To meet the MDM industry’s need to manufacture devices in a range of quantities and configurations, the same ZFUZE PEEK grade is available in the form of stock shapes for machining and pelletized resin for injection molding.
- Genesis Medical Plastics offers ZFUZE advanced PEEK in both material forms, and can assist with injection molding and machining guidelines.
Does ZFUZE PEEK reduce the risk of fibrous encapsulation of implants?
By driving a rapid transition from the pro-inflammatory M1 phase to the M2 phenotype, ZFUZE Advanced PEEK has been shown to mitigate fibrous encapsulation of implanted devices and promote pro-healing immunity.
Does Genesis offer production services for making parts in ZFUZE advanced PEEK?
- Genesis has extensive capabilities for injection molding ZFUZE resin and machining components from the stock shapes that the company extrudes from the biomaterial.
- The two processes are commonly used to produce precision parts in implantable polymers including ZFUZE advanced PEEK.
Are Studies Available on ZFUZE Advanced PEEK’s Bone On-Growth Efficacy?
- Extensive clinical test results are available on ZFUZE PEEK’s osteoconductive and osteoimmunological capabilities.
- In collaboration with ZFUZE™ PEEK developer DiFusion Therapeutic Biomaterials, Genesis provides access to all test data and reports required by device manufacturers.
Does ZFUZE PEEK have the bone-like modulus of natural implantable PEEK?
- A primary benefit of ZFUZE PEEK compared to titanium is its biomechanical compatibility with bone.
- Standard ASTM testing shows that the flexural modulus of ZFUZE PEEK closely approximates that of implantable natural PEEK grades from major resin suppliers.