CarboClear Pedicle Screw System
CarboClear fenestrated pedicle screws provide spinal support with High V+ Bone Cement in patients with advanced thoracic or lumbar tumors whose life expectancy is too short for fusion to…
CarboClear fenestrated pedicle screws provide spinal support with High V+ Bone Cement in patients with advanced thoracic or lumbar tumors whose life expectancy is too short for fusion to occur. This use provides limited-duration structural support and is restricted to spinal levels where structural integrity is not severely compromised.
The cannulated polyaxial screws have lateral openings near their distal tips. These openings allow controlled delivery of PMMA bone cement into the vertebral body. The screws are implanted with other components of the CarboClear Pedicle Screw System.
Listed Item
Fenestrated pedicle screw (oncology)
Construction
The screws are made from carbon-fiber-reinforced PEEK. A thin titanium shell surrounds the threaded portion, which includes a small tantalum marker. They are supplied sterile for single use.
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 | 2019-09-24 |
| Record revised | 2024-11-01 (version 4) |
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 | Length 35 to 55 mm; outer diameter 6.5 to 7.5 mm |
| Distribution end date | 2024-05-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedicle Screw – Fenestrated | Length 35 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Outer Diameter 6.5 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Length 55 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Outer Diameter 7.5 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Outer Diameter 7.5 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Length 55 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Length 45 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Length 45 mm | Withdrawn |
| Pedicle Screw – Fenestrated | Outer Diameter 6.5 mm | Withdrawn |
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 |
| CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 18 |
| 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 |
| 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.