CarboClear X Pedicle Screw System
CarboClear Fenestrated Pedicle Screws are used with High V+ Bone Cement to restore spinal column integrity for a limited time, even without fusion. The screw and cement form the specified…
CarboClear Fenestrated Pedicle Screws are used with High V+ Bone Cement to restore spinal column integrity for a limited time, even without fusion. The screw and cement form the specified temporary support combination.
The indication is for patients with advanced-stage tumors involving the thoracic or lumbar spine whose life expectancy is too short to permit fusion. This is the stated clinical population for the cement-augmented screws.
Listed Item
CarboClear X Dual Thread Pedicle Screw Fenestrated
Structural Use Restriction
The combination is limited to spinal levels where the structural integrity of the spine is not severely compromised.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | PML |
| Device type | Bone Cement, Posterior Screw Augmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Manufacturer |
| 510(k) | K190526 |
| Record published | 2022-01-16 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2 |
| Sizes | Outer diameter 5 to 7.5 mm; length 25 to 55 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedicle Screw – Fenestrated | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 55 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 25 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 55 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 45 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 45 mm | In distribution |
| Pedicle Screw – Fenestrated | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Outer Diameter 6.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 321 |
| M.u.s.t. Pedicle Screw System | Medacta International SA | 248 |
| CarboClear Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 153 |
| Viper | Medos International Sàrl | 32 |
| Expedium Verse | Medos International Sàrl | 26 |
| Vader Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 55 mm | Icotec AG | 13 |
| CarboClear Modular Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 11 |
| CarboClear Pedicle Screw System | CarboFix Orthopedics, Ltd. | 9 |
| icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm | Icotec AG | 6 |
| Vader Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 | Icotec AG | 1 |
| Romeo® 2 | Spineart SA | 1 |
| Vader Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm | Icotec AG | 1 |
Showing 12 of 14. All products under Bone Cement, Posterior Screw Augmentation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190526 | 2019-09-19 |
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.