Dec. 5 at 1:09 PM
$DDD Most people don’t realize how big a milestone 3D-printed PEEK cranial implants are. This wasn’t “print it and use it.” It took years of development, millions in validation, and heavy FDA scrutiny before a single patient received one.
PEEK is a top-tier implant material—biocompatible, strong, CT/MRI-friendly. But printing it consistently for skull reconstruction required solving huge challenges: high-temp chamber control, mechanical repeatability, sterility validation, CT-based accuracy, and ISO 13485 manufacturing.
FDA clearance alone requires biocompatibility tests, fatigue testing, sterilization proofs, packaging validation, and full reproducibility across machines.
Now top hospitals are adopting patient-specific PEEK implants because they fit better, reduce surgical time, lower complications, and improve cosmetic outcomes.
This is the part of AM that’s real, regulated, and hard to copy.
