PML · Bone Cement, Posterior Screw Augmentation
Orthopedic · 21 CFR 888.3027 · Class 2
Overview
| Product Code | PML |
|---|---|
| Device Name | Bone Cement, Posterior Screw Augmentation |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | Jan 22, 2026 | SESE |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | Jun 12, 2024 | SESE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | Ulrich Medical USA | Oct 20, 2023 | SESE |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | Jun 23, 2023 | SESE |
| K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | Jan 9, 2023 | SESE |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | Dec 20, 2022 | SESE |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | Aug 26, 2022 | SESE |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | Oct 28, 2021 | SESE |
| K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | Oct 13, 2020 | SESE |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | Medtronic | Aug 19, 2020 | SESE |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | Mar 31, 2020 | SESE |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics , Ltd. | Sep 19, 2019 | SESE |
| K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | Sep 12, 2019 | SESE |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | Nov 28, 2018 | SESE |
| K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System | Globus Medical, Inc. | Mar 27, 2018 | SESE |
| K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | Oct 23, 2017 | SESE |
| K160879 | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems | Medos International Sàrl | Dec 20, 2016 | SESE |
| K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | Jan 6, 2016 | SESE |
Top Applicants
- Neo Medical SA — 2 clearances
- Medtronic — 2 clearances
- Icotec AG — 2 clearances
- Ulrich Medical USA — 1 clearance
- Stryker Corporation — 1 clearance
