PML — Bone Cement, Posterior Screw Augmentation Class II
FDA product code PML covers "Bone Cement, Posterior Screw Augmentation", a Class II medical device regulated under 21 CFR 888.3027. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 19 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260286 | Spine Wave | Dynamo Spinal Cement; Salvo® Spine System | Jun 15, 2026 |
| K252885 | Astura Medical | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Jan 22, 2026 |
| K241034 | Medacta International | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Jun 12, 2024 |
| K231809 | Ulrich Medical Usa | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Oct 20, 2023 |
| K230774 | Spineart | PERLA® TL System; TEKTONA® HV US Bone Cement | Jun 23, 2023 |
| K222789 | Icotec | VADER® Pedicle System, G21 Cement | Jan 9, 2023 |
| K221926 | Alphatec Spine | Invictus® Bone Cement, Invictus Spinal Fixation System | Dec 20, 2022 |
| K222256 | Neo Medical | BonOs® Inject Bone Cement; NEO Pedicle Screw System | Aug 26, 2022 |
| K212489 | Neo Medical | BonOs Inject Bone Cement; NEO Pedicle Screw System | Oct 28, 2021 |
| K200596 | Icotec | G21 Cement, VADER® Pedicle System | Oct 13, 2020 |
| K201362 | Medtronic | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone… | Aug 19, 2020 |
| K192818 | Stryker Corporation | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal… | Mar 31, 2020 |
| K190526 | Carbofix Orthopedics | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | Sep 19, 2019 |
| K191148 | Medtronic Sofamor Danek Usa | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated… | Sep 12, 2019 |
| K180498 | Nu Vasive, Incorporated | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nov 28, 2018 |
| K172269 | Globus Medical | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO®… | Mar 27, 2018 |
| K171938 | Medtronic | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Oct 23, 2017 |
| K160879 | Medos International Sàrl | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw… | Dec 20, 2016 |
| K152604 | Medtronic Sofamor Danek Usa, Incorporated | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Jan 6, 2016 |