Customized Skull Implant (CSI)
Customized Skull Implant is a patient-specific PEEK plate for filling a bony defect in the skull. Its size, shape, contour, edge profile and thickness are designed from the patient's CT…
Customized Skull Implant is a patient-specific PEEK plate for filling a bony defect in the skull. Its size, shape, contour, edge profile and thickness are designed from the patient’s CT data. The implant is intended for a single patient and is non-load-bearing.
The base implant is machined from implant-grade PEEK and attached to native bone with cranioplasty hardware and fasteners. It is supplied clean but nonsterile for steam sterilization before implantation in a hospital or surgical facility with neurosurgical capabilities.
Listed Item
PEEK Customized Skull Implant, X-LARGE CSI061526-VA1
Patient-Specific Design Range
The described implant range spans thicknesses of 2 to 10 mm and widths and lengths of 25 to 250 mm. Optional perfusion holes permit fluid passage. Integrated fixation tabs can instead accept cranioplasty screws directly, according to the physician-requested design.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
Record
| Listed by | Kelyniam Global Inc., United States |
|---|---|
| FDA product code | GWO |
| Device type | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5320 |
| Establishment | Manufacturer |
| 510(k) | K182711 |
| Record published | 2026-04-30 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-07-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PEEK-IM1002 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1003 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1002 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1003 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1003 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1001 | Withdrawn | |
| PEEK-IM1004 | Withdrawn | |
| PEEK-IM1003 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 103 |
| Plate, Cranioplasty, Preformed, Alterable | Stryker Leibinger Gmbh & Co. KG | 93 |
| 1.5MM System | Biomet Microfixation | 72 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 35 |
| 2.0MM System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 26 |
| Plate, Cranioplasty, Preformed, Alterable | Biomet Microfixation | 22 |
| Innovasis® Cranial System | Inno-Health Technology Co., Ltd. | 21 |
| NeuroPro® Low Profile | Kinamed, Inc. | 16 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 14 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 11 |
| “1.0MM” System | Biomet Microfixation | 10 |
Showing 12 of 45. All products under Plate, Cranioplasty, Preformed, Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250334 | 2025-07-25 |
| K182711 | 2019-05-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.