ZFUZE™ PEEK Comprehensive Overview

Why ZFUZE Advanced PEEK?

ZFUZE PEEK was developed as an osteoconductive biomaterial that combines the bone-like modulus of natural PEEK with the bone on-growth benefits associated with titanium alloy implants. These two desirable attributes previously had not been available in a single, homogeneous implantable material.

It also has PEEK’s inherent radiolucency, an advantage over titanium that allows surgeons to more clearly assess post-operative healing and adjacent structures in medical imaging.

In addition, studies show that the biomaterial’s unique composition supports immunomodulation by facilitating a rapid transition from the early and necessary pro-inflammatory M1 phase to the pro-healing M2 phenotype in 4-5 days. This transition promotes pro-healing immunity and mitigates fibrous encapsulation of implanted devices.

ZFUZE PEEK rod, plate and film stock shapes beside flasks of ZFUZE PEEK resin pellets

How is ZFUZE PEEK Different from Natural PEEK?

ZFUZE PEEK is a composite consisting of ceramic zeolites uniformly integrated into implantable grade PEEK resin. The zeolites provide the biomaterial’s osteoconductivity and pro-healing benefits over natural PEEK.

What are the Benefits of ZFUZE PEEK Compared to Natural PEEK?

  • Without compromising the bone-like modulus and radiolucency of natural PEEK, the zeolites in ZFUZE biomaterial impart osteoconductivity that promotes bone cell growth.
  • Zeolites in the composite material also support immunomodulation which facilitates fast and effective bone healing and growth.

What are the Benefits of ZFUZE PEEK Compared to Titanium Alloys?

While titanium alloys are recognized for osteointegrative properties, ZFUZE PEEK provides several benefits over the metallic materials for many applications:

  • ZFUZE PEEK is biomechanically compatible with bone.
    • ZFUZE PEEK has a modulus or stiffness in the range of bone, whereas the modulus of titanium is far higher.
    • The metal alloy’s high rigidity can impede healing and create stress shielding and the need for surgical revisions.
  • ZFUZE PEEK affords clear imaging.
    • With the inherent radiolucency of PEEK, ZFUZE biomaterial facilitates imaging and the ability to monitor healing and assess adjacent structures.
    • As a metallic material, titanium has the drawback of radiopacity that interferes with medical imaging methods.
  • ZFUZE PEEK mitigates fibrous encapsulation without surface treatments.
    • Certain titanium versions use surface treatments to reduce the risk of fibrous encapsulation.
    • These surface treatments may pose risks to immune responses, long-term biocompatibility and other factors that can impede their overall efficacy.

Summary of ZFUZE PEEK, Natural PEEK and Titanium Attributes for Implants

Table 1 provides a brief summary that compares the three materials on the major factors related to spinal and other bone-related surgical implants.

Table 1 comparing ZFUZE PEEK composite, natural PEEK and titanium on osteoconductivity, bone-like modulus, bone-like microporous surface, mitigating fibrous encapsulation, hydrophilic properties and radiolucency

The Science Behind ZFUZE PEEK’s Performance

  • In its natural state, the PEEK polymer is inert and hydrophobic, attributes that do not readily promote bone on-growth.
  • Zeolites in the ZFUZE formulation create a negatively charged hydrophilic surface on implants made from the biomaterial.
  • This surface provides an ideal electrostatic substrate for bonding positively charged RGD peptides.
  • The resultant bioactive interface attracts bone-forming cells and accelerates osseointegration.
  • The microporous structure also serves as an optimal interface for bone cell attachment and growth.
  • In addition, the zeolites facilitate a rapid M1-to-M2 transition that mitigates fibrous encapsulation, enabling faster healing and cell growth.

How ZFUZE Advanced PEEK Composite Works

Diagram of how zeolites in ZFUZE advanced PEEK create a negatively charged hydrophilic surface that binds RGD peptides, with a cross section of the ZFUZE PEEK matrix, compared with the inert surface of natural PEEK

FDA-cleared as an Immuno-modulating Biomaterial

Advances in the science of immune-mediated tissue response has led to a paradigm shift favoring biomaterials that modulate the immune system rather than simply tolerating it. Specifically, immunomodulation as characterized by the shift from the inflammatory M1 state to the pro-healing M2 state is seen as a key driver of post-surgical tissue regeneration.

ZFUZE PEEK holds a unique position in this regard as the first and only FDA-cleared immuno-modulating biomaterial.

Biocompatibility Documentation for ZFUZE PEEK

  • A ZFUZE FDA Master File with a comprehensive battery of ISO tests (Table 2) and FDA 501(k) submission data are available to support MDMs.

  • The ISO 10993 tests were commissioned by DiFusion Technologies, Inc, the company that developed the ZFUZE PEEK composite.  Genesis Medical Plastics works collaboratively with DiFusion Technologies who developed the ZFUZE composite and can provide access to information and reports that MDMs may require. 

Download biocompatibility tests summary and physical properties data sheet.

Table 2 listing the ZFUZE PEEK biocompatibility tests and the ISO 10993 method used for each

ZFUZE Advanced PEEK Stock Shapes for Machining

Genesis Medical Plastics extrudes ZFUZE PEEK resin into a range of standard rod diameters for machining into precision components. Custom rod diameters and plate in a variety of thicknesses are also available on request.

Three extruded ZFUZE PEEK rods in a range of diameters

Machinable Stock Shapes – ZFUZE Advanced PEEK

  • Standard rod diameters: 6mm – 40mm.
  • Standard plate thicknesses: 6mm – 25mm.
    • Standard width: 305mm; Maximum width: 610mm
  • Custom sizes including larger diameter rod and thicker plate available on request.
    • Reasonable minimums support product development.

ZFUZE Advanced PEEK Resin for Injection Molding

To enable production of medical devices in a range of quantities and configurations, Genesis Medical Plastics offers the same ZFUZE PEEK grade in the form of pelletized resin for injection molding in addition to stock shapes for machining.  Injection molding is typically chosen as devices transition to higher production volumes, while machining is ideal for smaller manufacturing runs and components with complex design features that cannot be molded easily due to tool design constraints.

Genesis Production Capabilities for Implantable Devices

Genesis supports customers’ ability to bring medical products to market with its ISO 13485:2016 and ISO 9001:2015 certification and FDA registration as a device manufacturing facility. In-house capabilities for the production of implantable devices made from ZFUZE Advanced PEEK and other medical polymers include both machining and injection molding. Genesis also offers prototyping to support product development.

Specifications –

MACHINABLE STOCK SHAPES

Standard rod diameters – mm

  • 6mm – 40mm.

Plate dimensions – mm

  • Standard thicknesses: 6mm – 25mm.
  • Standard width: 305mm
  • Maximum width: 610mm

Custom sizes including larger diameter rod and thicker plate available on request.

  • Reasonable minimums support product development.
ZFUZE PEEK Data Sheet

FAQ's ​About ZFUZE Advanced PEEK

  • The osteoconductive properties of ZFUZE biomaterial are a benefit for devices used in spinal surgery and other bone-related procedures.

ZFUZE PEEK supports immunomodulation, rapidly shifting macrophages from the pro-inflammatory M1 phase to the pro-healing M2 phenotype. This transition mitigates fibrous encapsulation and supports bone cell adhesion, growth and faster healing.
  • Genesis can provide results of several clinical studies done on ZFUZE PEEK.
  • Examples of the efficacy of ZFUZE PEEK’s performance include:
    • A 75-patient retrospective study showing 98.4% lumbar spinal fusion rate at 6 months vs. an average of 68% in 12 months for competitive materials.
    • A 98% fusion rate at 8 months with 0% device migration (NASS case series).
  • A primary benefit of ZFUZE PEEK compared to titanium is its biomechanical compatibility with bone.
  • Standard ASTM testing places the flexural modulus of ZFUZE PEEK in the same range as implantable grades of natural PEEK from major resin suppliers.
  • Extruded shapes and resin are available in the same grade of ZFUZE PEEK, allowing MDMs to more easily transition from machining to injection molding as quantity requirements grow over a device’s life cycle.
Extruded ZFUZE PEEK rods alongside machined ZFUZE PEEK spinal cage components
Spinal cages machined from ZFUZE rod.
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