ClearFit
Longeviti ClearFit OTS Cranial Implants are intended to correct or restore bony voids and defects of the cranium. The filing describes the implants as polymethyl methacrylate devices…
Longeviti ClearFit OTS Cranial Implants are intended to correct or restore bony voids and defects of the cranium. The filing describes the implants as polymethyl methacrylate devices provided sterile.
The summary states that the implants can be fixed to cranial bone using commercially available fasteners. This description is limited to the specified cranial defect-restoration role and stated material.
Listed Item
Complex Static Cranial Implant (Primary and Backup)
Device Material and Fixation
The FDA summary identifies the subject product as ClearFit OTS Cranial Implants and describes its material and fixation method. The device is supplied sterile.
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 | Longeviti Neuro Solutions, United States |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K212058 |
| Record published | 2020-03-09 |
| Record revised | 2026-01-22 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: See special handling instructions; Handling environment temperature 59 to 86 % RH; Storage environment humidity 0 to 70 % RH; Storage environment temperature 59 to 86 °F |
| Packaging | Case of 2 |
| Sizes | Area/surface area 37 to 60 Square centimeter |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 171709 | Area/Surface Area 37 Square centimeter | In distribution |
| 171715 | In distribution | |
| 171726 | In distribution | |
| 991714 | In distribution | |
| 171712 | Area/Surface Area 60 Square centimeter | In distribution |
| 991713 | In distribution | |
| 171707 | In distribution | |
| 991712 | In distribution | |
| 171717 | In distribution | |
| 171702 | In distribution | |
| 171706 | In distribution | |
| 991711 | In distribution | |
| 171705 | In distribution | |
| 171727 | In distribution | |
| 171701 | In distribution | |
| 171700 | In distribution | |
| 171737 | In distribution | |
| 171738 | In distribution | |
| 171736 | In distribution | |
| 171719 | In distribution | |
| 991710 | In distribution | |
| 171704 | In distribution | |
| 171735 | In distribution | |
| 171714 | Area/Surface Area 60 Square centimeter | In distribution |
| 171710 | Area/Surface Area 60 Square centimeter | In distribution |
| 171703 | 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 |
| 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 |
|---|---|
| K260709 | 2026-06-25 |
| K231920 | 2023-11-09 |
| K212058 | 2021-09-08 |
| K210616 | 2021-03-31 |
| K203349 | 2020-12-16 |
| K202901 | 2020-10-30 |
| K191210 | 2020-01-09 |
| K170410 | 2018-03-23 |
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.