Customized Craniofacial Implant (CCI)
The Customized Craniofacial Implant fills a patient specific bony void or defect in the craniofacial skeleton. Its stated anatomical scope includes the orbital rim, zygoma and adjacent…
The Customized Craniofacial Implant fills a patient specific bony void or defect in the craniofacial skeleton. Its stated anatomical scope includes the orbital rim, zygoma and adjacent bone. The implant is shaped for the individual patient using CT scan data.
The implant is machined from a block of implant grade PEEK. The patient’s scan geometry guides the design of the plate so it corresponds to the defect area. Features required for the surgical application can be incorporated during that design and machining process.
Listed Item
PEEK Customized Craniofacial Implant, LARGE CCI060826-MB1
Supply
The implant is supplied nonsterile and requires preparation and sterilization before implantation. The material and configuration concern the implant itself.
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 | 2026-06-10 |
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 | 2026-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PEEK-IM2003 | Withdrawn |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 |
| Customized Skull Implant (CSI) | Kelyniam Global Inc. | 49 |
| 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 |
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.