Kelyniam CSI
Kelyniam CSI is a patient-specific cranial implant that replaces a bony void in the skull. Its size and shape are designed for the individual defect using the patient’s CT imaging data. The…
Kelyniam CSI is a patient-specific cranial implant that replaces a bony void in the skull. Its size and shape are designed for the individual defect using the patient’s CT imaging data.
The cranioplasty plate is PEEK-OPTIMA polymer. Pressure-relief holes are distributed across its contour, while commercially available cranioplasty fasteners attach the implant to the remaining native bone.
Listed Item
PEEK Customized Cranial Implant, 3-Piece Implant: Small, small, and small
Custom Implant Supply
Each implant is individually fabricated for the prescribed cranial reconstruction. The devices are supplied nonsterile for sterilization before implantation and are intended for single use. The custom geometry, pressure-relief holes and separate fixation fasteners serve distinct parts of the reconstruction.
3manufacturers in China registered for this device type
1,714catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shaanxi (1). 3 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 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Kelyniam Global Inc., United States |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| Establishment | Manufacturer |
| 510(k) | K103582 |
| Record published | 2023-04-17 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-04-14 |
Catalogue Numbers
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| PEEK-IM1003 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HTR-Pekk | Oxford Performance Materials, Inc. | 4,551 |
| Plate, Cranioplasty, Preformed, Non-Alterable | Synthes Gmbh | 263 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour (Xi’an) Medical Technology Co., Ltd. | 162 |
| CranioFit | Bioplate, Inc. | 161 |
| IPS | KLS-Martin L.P. | 74 |
| AccuShape | MedCAD | 27 |
| ClearFit | Longeviti Neuro Solutions | 26 |
| IPS, Sterile | KLS-Martin L.P. | 18 |
| Level ONE Thoracic, Sterile | KLS-Martin L.P. | 14 |
| Meticuly Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 13 |
| Bioplate® | Bioplate, Inc. | 13 |
| Invisx™ | Medtronic PS Medical | 12 |
Showing 12 of 32. All products under Plate, Cranioplasty, Preformed, Non-Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121755 | 2012-09-25 |
| K103582 | 2011-04-14 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Kelyniam Global Inc. | 510(k) number | 2017-06-10 | Class II | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA | 2 | 2020-09-14 |
| Kelyniam Global Inc. | 510(k) number | 2017-06-10 | Class II | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA | 16 | 2020-09-14 |
| Kelyniam Global Inc. | 510(k) number | 2017-06-10 | Class II | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA | 23 | 2020-09-14 |
| Kelyniam Global Inc. | 510(k) number | 2017-06-10 | Class II | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA | 54 | 2020-09-14 |
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.