ZFUZE™ PEEK Comprehensive Overview

Why ZFUZE Advanced PEEK?

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

Unlike titanium, the polymeric ZFUZE biomaterial also offers radiolucency in medical imaging that allows surgeons to clearly assess bone healing and growth.

How Does ZFUZE PEEK Differ from Natural PEEK?

  • ZFUZE PEEK is a composite material formulated from natural PEEK polymer and ceramic zeolites.
  • It has the inherent modulus and radiolucency benefits of natural PEEK for long-term implants.
  • The zeolites integrated into the polymer matrix provide the added benefit of osteoconductivity that promotes bone cell growth.

Benefits of ZFUZE PEEK vs. Titanium and Natural PEEK

While titanium is recognized for its osteointegrative properties, it has shortcomings for many applications. Its modulus or stiffness is far higher than that of bone, which can impede healing and create stress shielding and the need for surgical revisions. In addition, its radiopacity associated with metals interferes with medical imaging methods that monitor healing.

Compared to natural PEEK, ZFUZE biomaterial offers osteoconductivity that more effectively supports bone cell growth.

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

How the ZFUZE PEEK Composite Achieves Osteoconductivity

  • In its natural state, the PEEK polymer is inert and hydrophobic. These attributes do not readily promote bone on-growth.
  • The zeolites in the ZFUZE composite impart a negative charge to PEEK and also give it hydrophilic properties.
  • This combination creates an ideal electrostatic substrate for bonding positively charged RGD peptides to implants made from the composite biomaterial.
  • Zeolite molecules also enable controlled release of Metallic Ion Therapeutic Agents (MITAs). 
  • The synergy creates a bioactive interface on the surface of implants made from ZFUZE PEEK that attracts bone-forming cells and accelerates osseointegration (Illustration 1). 
  • The microporous structure of the zeolites on the surface of implants made from ZFUZE PEEK also provides an optimal interface for bone cell attachment and growth.

How ZFUZE Advanced PEEK Composite Works

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.

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.

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.
  • 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.
  • The availability of shapes and resin in the same grade of ZFUZE PEEK allows MDMs to more easily transition from machining to injection molding as quantity requirements grow over a device’s life cycle.
Spinal cages machined from ZFUZE rod.
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