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All topics
  1. What it is
  2. Why it matters
  3. Timing
  4. The procedure
  5. Patient journey
  6. Recovery supplies
  7. Implant materials
  8. Side-by-side
  9. US manufacturers
  10. What the evidence says
  11. Value analysis
  12. Questions to ask
  13. Glossary
  14. Resources
  15. References

US market

Manufacturers available in the United States

These companies market alloplastic cranial implants in the US. Most cranial implants reach the market through FDA 510(k) clearance as Class II devices, which is why you will usually see "FDA cleared" rather than "FDA approved."

Listed alphabetically. Compiled October 2026 from public company pages, FDA documents and press releases linked on each card. This list may not be complete and product lines change, so confirm current status in the FDA 510(k) database. Drawings show the implant material type and are not product photos; each company's site has photos of its actual products.

PEEK

3D Systems

VSP PEEK Cranial Implant

Material
PEEK
How it's made
Patient-specific, 3D printed (additive manufacturing)
US status
510(k) cleared April 2024; described as the first FDA-cleared additively manufactured PEEK cranial implant
Company websiteClearance source
Printed titanium

CGBIO

EASYMADE TI

Material
Medical-grade titanium alloy
How it's made
Patient-specific, laser powder bed fusion (metal 3D printing)
US status
510(k) clearance announced April 2026. Newly cleared; confirm US availability with the company.
Company websiteClearance source
Material not disclosed

CraniUS Therapeutics

CraniUS Plate

Material
Not specified in the public announcement
How it's made
Patient-specific; Class II preformed alterable cranioplasty plate
US status
510(k) cleared July 2026, announced September 2026. The company's broader brain-access platform remains investigational.
Company websiteClearance source
PEEK
Titanium

J&J MedTech (DePuy Synthes)

TRUMATCH CMF Patient Specific Implant

Material
PEEK; commercially pure titanium
How it's made
Patient-specific, designed from CT data
US status
Marketed on the company's US site for cranial and craniofacial bony voids
Product page
PEEK
BCP-PEEK
HA ceramic

Kelyniam Global

Custom PEEK Implants; FUSION BCP-PEEK

Material
PEEK; biphasic calcium phosphate reinforced PEEK. The site also lists hydroxyapatite (CustomizedBone) and resorbable PCL burr hole products.
How it's made
Patient-specific, made in Connecticut
US status
Custom PEEK cranial implant cleared 2011; FUSION BCP-PEEK cleared September 2025
Company websitePEEK 510(k)FUSION source
PEEK
Titanium mesh
Solid titanium

KLS Martin

IPS Implants Cranium

Material
PEEK; titanium mesh; solid titanium; additively manufactured titanium
How it's made
Patient-specific, by 3D printing or conventional milling and forming
US status
Marketed in North America through KLS Martin LP; the company notes not every product is available in every market
Product pageUS device listing
PMMA

Longeviti Neuro Solutions

ClearFit (Patient Specific and Off-the-Shelf)

Material
PMMA
How it's made
Patient-specific from CT, or off-the-shelf sterile shapes and sizes. Designed to allow ultrasound imaging through the implant after surgery.
US status
510(k) cleared December 2020 (K203349)
Company websiteFDA 510(k)
PEEK
Titanium

MedCAD

AccuShape Cranial Implants

Material
PEEK; titanium (milled grade 2, and 3D printed per company site)
How it's made
Patient-specific, designed from CT data
US status
AccuShape Titanium cleared August 2022 (K220357)
Company websiteClearance record
Printed titanium

Meticuly

Patient-Specific Titanium Cranial Mesh

Material
Titanium alloy (Ti-6Al-4V ELI)
How it's made
Patient-specific, laser powder bed fusion (metal 3D printing)
US status
510(k) clearance announced December 2021
Company websiteClearance source
PEEK
Porous PE

Stryker

Cranial iD (PEEK and MEDPOR Customized Implants)

Material
PEEK; MEDPOR porous polyethylene
How it's made
Patient-specific. PEEK offered with or without a surgeon design session; MEDPOR can be trimmed with a scalpel in surgery.
US status
Marketed on the company's US site
Product page
PEKK / PEEK
Titanium
Porous PE

Zimmer Biomet

One2One Cranial (PEKK, PEEK, Titanium)

Material
PEKK; PEEK; titanium. Also lists CranioCurve preformed mesh and Omnipore porous polyethylene.
How it's made
Patient-matched
US status
Marketed on the company's US site
Product page

PEKK (polyetherketoneketone) is a high-performance plastic from the same family as PEEK. No longer offered: OssDsign discontinued its cranial patient-specific implant business at the end of 2023 (source).

Value analysis

When comparing vendors, ask each one for its 510(k) number and cleared indications, instructions for use, design review process, typical lead time from CT to delivery, sterilization and delivery method, and pricing for stock versus patient-specific options.