Zeniva ZA-500 PEEK

Ratings describe the resin's general behaviour, not your part. Moulded-in stress, wall section, temperature and applied load all change the outcome — qualify the finished device with your own cleaning and exposure protocol.

Maximum dose and cycle counts require producer validation data, so we show "Confirm with producer" rather than a figure. Retention and discoloration notes are qualitative. Sterilization must always be validated on the finished device.

• USP Class VIYes
• ISO 10993-1 (biological evaluation)Yes
• ISO 10993-4 (blood interaction)Yes
• ISO 10993-5 (cytotoxicity)Yes
• ISO 10993-6 (implantation)Yes
• ISO 10993-10 (irritation / sensitization)Yes
• ISO 10993-11 (systemic toxicity)Yes
• FDA Drug Master FileYes
• EU MDR statusAwaiting confirmation
• Food contact statusAwaiting confirmation
• REACH SVHCAwaiting confirmation
• RoHSAwaiting confirmation
• Animal-derived-free / TSE-BSEYes
• DEHP-freeYes
• Phthalate-freeYes
• BPA-freeYes
• Latex-freeYes
• California Prop 65Awaiting confirmation

Compliance status reflects producer statements and grade records on file. Always confirm the current position with a signed regulatory statement letter for your specific device and market before submission.

Cross-references indicate a similar material family, not a guaranteed drop-in. Qualify any substitution against your own part and process.

Can Zeniva ZA-500 PEEK be autoclaved repeatedly?

Yes. A 134 °C steam cycle sits well below this grade's 150 °C glass transition and far below its 340 °C melting point, and PEEK does not hydrolyse in wet heat, so it tolerates repeated cycles. This is the main reason it is specified for reusable instrument components alongside implants.

Why is PEEK used for spinal fusion cages instead of titanium?

Two reasons. Its elastic modulus is close to cortical bone, so load is shared with the surrounding bone rather than carried entirely by the implant, which reduces stress shielding. It is also radiolucent, so surgeons can assess fusion and bone in-growth on post-operative imaging without the metal artefact titanium produces on CT.

Is Zeniva ZA-500 qualified for permanent implant contact?

Yes. The grade record classifies it for permanent contact, meaning more than 30 days under ISO 10993-1, and it carries USP Class VI along with ISO 10993 parts 1, 3, 5, 6 and 11. Part 6 implantation testing is the gating requirement for permanent-contact devices, and it is covered.

What sterilization methods can I use with Zeniva ZA-500 PEEK?

The grade record lists gamma, e-beam, ethylene oxide, steam autoclave and dry heat, which is unusually broad and gives you real freedom in process design. X-ray and vaporized hydrogen peroxide are not listed but are chemically and thermally undemanding for PEEK, so they are likely workable subject to your own validation. We do not publish maximum dose figures — confirm those with Solvay.

Is Zeniva ZA-500 available as rod stock for machining?

Yes. It is supplied as both pellet and rod stock, so you can machine prototypes and low-volume implants from rod and move to injection moulding at production volume. Note that machined and moulded parts can differ in crystallinity and residual stress, so qualification data does not transfer automatically between the two routes.

How does PEEK resistance to disinfectants compare with polycarbonate?

Considerably better. PEEK has no hydrolysable linkage in its backbone and is not prone to environmental stress cracking, so alcohols, quat disinfectants, hypochlorite wipes, acetone and DMSO are all tolerated. Polycarbonate crazes in alcohols and lipids and is degraded by hypochlorite. If repeated aggressive wipe-down is part of the device's life, PEEK removes a whole class of failure mode.