Bone Cement, Posterior Screw Augmentation
FDA product code PML · Class II (moderate risk) · 21 CFR 888.3027 · Orthopedic
The device is intended to augment the fixation of screws in a posterior spinal system construct.
19510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Manufacturers
- Medtronic Sofamor Danek USA, Inc. 2
- Medtronic, Inc. 2
- Icotec AG 2
- Neo Medical SA 2
- Medos International Sàrl 1
- Globus Medical, Inc. 1
- Nu Vasive, Incorporated 1
- CarboFix Orthopedics , Ltd. 1
- Stryker Corporation 1
- Alphatec Spine, Inc. 1
- Spineart 1
- Ulrich Medical USA 1
- Medacta International S.A. 1
- Astura Medical 1
- Spine Wave, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | Spine Wave, Inc. | 06/15/2026SE |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | Astura Medical | 01/22/2026SE |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPML · Traditional | Medacta International S.A. | 06/12/2024SE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…PML · Traditional | Ulrich Medical USA | 10/20/2023SE |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone CementPML · Traditional | Spineart | 06/23/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | Icotec AG | 01/09/2023SE |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation SystemPML · Traditional | Alphatec Spine, Inc. | 12/20/2022SE |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw SystemPML · Special | Neo Medical SA | 08/26/2022SE |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw SystemPML · Traditional | Neo Medical SA | 10/28/2021SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | Icotec AG | 10/13/2020SE |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone CementPML · Traditional | Medtronic | 08/19/2020SE |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPML · Traditional | Stryker Corporation | 03/31/2020SE |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsPML · Traditional | CarboFix Orthopedics , Ltd. | 09/19/2019SE |
| K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw SetPML · Traditional | Medtronic Sofamor Danek USA, Inc. | 09/12/2019SE |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone CementPML · Traditional | Nu Vasive, Incorporated | 11/28/2018SE |
| K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw…PML · Traditional | Globus Medical, Inc. | 03/27/2018SE |
| K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetPML · Traditional | Medtronic | 10/23/2017SE |
| K160879 | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsPML · Traditional | Medos International Sàrl | 12/20/2016SE |
| K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetPML · Traditional | Medtronic Sofamor Danek USA, Incorporated | 01/06/2016SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0701-2024 Class II | VADER pedicle system, torque wrench, Catalog Number 42-703icotec has received notification of one revision that had to be carried out because nut screws had become… | Icotec Ag | 11/28/2023Open, Classified |
| Z-0700-2024 Class II | VADER pedicle system, torque wrench, Catalog Number 42-702icotec has received notification of one revision that had to be carried out because nut screws had become… | Icotec Ag | 11/28/2023Open, Classified |