Kelynaim CSI
PEEK Customized Cranial Implant, X-Large
3manufacturers in China registered for this device type
3catalogue 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 |
| Record published | 2016-12-07 |
| Record revised | 2018-03-29 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PEEK-IM1004 | In distribution | |
| PEEK-IM1004 | In distribution | |
| PEEK-IM1004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HTR-Pekk | Oxford Performance Materials, Inc. | 4,551 |
| Kelyniam CSI | Kelyniam Global Inc. | 1,714 |
| 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 |
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
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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.