PML — Bone Cement, Posterior Screw Augmentation Class II
Classification Details
- Product Code
- PML
- Device Class
- Class II
- Regulation Number
- 888.3027
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252885 | astura medical | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | January 22, 2026 |
| K241034 | medacta international | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | June 12, 2024 |
| K231809 | ulrich medical usa | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment | October 20, 2023 |
| K230774 | spineart | PERLA® TL System; TEKTONA® HV US Bone Cement | June 23, 2023 |
| K222789 | icotec | VADER® Pedicle System, G21 Cement | January 9, 2023 |
| K221926 | alphatec spine | Invictus® Bone Cement, Invictus Spinal Fixation System | December 20, 2022 |
| K222256 | neo medical | BonOs® Inject Bone Cement; NEO Pedicle Screw System | August 26, 2022 |
| K212489 | neo medical | BonOs Inject Bone Cement; NEO Pedicle Screw System | October 28, 2021 |
| K200596 | icotec | G21 Cement, VADER® Pedicle System | October 13, 2020 |
| K201362 | medtronic | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone | August 19, 2020 |
| K192818 | stryker corporation | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal Syste | March 31, 2020 |
| K190526 | carbofix orthopedics | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | September 19, 2019 |
| K191148 | medtronic sofamor danek usa | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated | September 12, 2019 |
| K180498 | nu vasive, incorporated | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | November 28, 2018 |
| K172269 | globus medical | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrat | March 27, 2018 |
| K171938 | medtronic | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | October 23, 2017 |
| K160879 | medos international sàrl | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw | December 20, 2016 |
| K152604 | medtronic sofamor danek usa, incorporated | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | January 6, 2016 |