ISO 9001:2015ITAR RegisteredRoHS · REACHLead time from 3 business daysMOQ = 1 part
PifyC
Services
Materials
Industries
Applications
Resources
Locations
Company
Request a quote
5-axis CNC milling drawing: Al 7075-T6 block with pockets, toolpath and dimensions
Custom · Implants

Patient-specific. FDA-grade. Implant-quality.

Custom medical implants — orthopedic, dental, spinal, cranial. Titanium Ti-6Al-4V ELI, PEEK-OPTIMA, surgical stainless. ISO 13485-compatible documentation.

Material-specific partsWuxi, ChinaMOQ 1 partDFM review included
Technical plate for Patient-specific. FDA-grade. Implant-quality.
How we run it

Custom medical implants

Custom implants serve patient-specific surgical needs. Material biocompatibility, manufacturing precision, surface quality all matter for implant performance.

3-7 daysTypical lead time
MOQ 1No minimum quantity
<4 hQuote response
ISO 9001Quality system
01 · Implant categories

What we manufacture.

Custom implants serve patient-specific surgical needs. Material biocompatibility, manufacturing precision, surface quality all matter for implant performance.

Get an instant quote

Send your CAD — we reply with detailed pricing, lead time, and DFM feedback within 4 working hours.

Talk to an engineer

WhatsApp our team directly. Most messages answered within 12 minutes during work hours.

Explore all services

CNC, 3D printing, injection molding, sheet metal, casting, finishing — one quality system, one partner.

FAQ

Patient-specific — questions

FDA approval needed?

Customer holds FDA 510(k) clearance for implant product. We manufacture per customer-approved drawings/specs. Customer manages FDA submission.

Material biocompatibility?

We use FDA-listed materials with USP Class VI testing where applicable. Material certs accompany each lot. Specific material per implant: PEEK-OPTIMA, Ti-6Al-4V ELI, 316LVM stainless.

Patient-specific manufacturing?

From customer CT/MRI imaging (DICOM format) we machine implants matching individual anatomy. CAD model generated, customer reviews, then manufactured.

Cleanroom requirement?

Final cleaning in ISO 7 cleanroom. Particle-controlled packaging. Sterile-ready (customer sterilizes per validated process).

Lead time?

Patient-specific implants 2-4 weeks from data receipt. Production implants per customer scheduling.

Documentation included?

Material certificates, dimensional inspection, lot/serial number, surface finish documentation. Format per customer ISO 13485 requirements.

5-axis CNC milling drawing: Al 7075-T6 block with pockets, toolpath and dimensions

Send a CAD file. Get an engineering-reviewed quote.

No minimum quantity, free DFM feedback from a senior manufacturing engineer, and an NDA signed before file review on request.