PML · Class II · 21 CFR 888.3027

FDA Product Code PML: Bone Cement, Posterior Screw Augmentation

Under FDA product code PML, posterior pedicle screw augmentation bone cements are cleared to enhance screw fixation in osteoporotic or compromised bone.

These injectable calcium phosphate or PMMA cements are delivered through cannulated pedicle screws to fill the surrounding cancellous bone and increase the pullout strength of the screw, particularly in elderly patients with osteoporosis where standard fixation may be insufficient.

PML devices are Class II medical devices, regulated under 21 CFR 888.3027 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Icotec AG, Neo Medical SA and Medtronic.

18
Total
18
Cleared
147d
Avg days
2016
Since
Declining activity - 1 submissions in the last 2 years vs 6 in the prior period
Consistent review times: 134d avg (recent)

FDA 510(k) Cleared Bone Cement, Posterior Screw Augmentation Devices (Product Code PML)

18 devices
1–18 of 18
Cleared Jan 22, 2026
OLYMPIC Posterior Spinal Fixation System
K252885
Astura Medical
Orthopedic · 134d
Cleared Jun 12, 2024
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K241034
Medacta International S.A.
Orthopedic · 57d
Cleared Oct 20, 2023
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
K231809
Ulrich Medical USA
Orthopedic · 122d
Cleared Jun 23, 2023
PERLA® TL System
K230774
Spineart
Orthopedic · 94d
Cleared Jan 09, 2023
VADER® Pedicle System, G21 Cement
K222789
Icotec AG
Orthopedic · 116d
Cleared Dec 20, 2022
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926
Alphatec Spine, Inc.
Orthopedic · 172d
Cleared Aug 26, 2022
BonOs® Inject Bone Cement
K222256
Neo Medical SA
Orthopedic · 30d
Cleared Oct 28, 2021
BonOs Inject Bone Cement
K212489
Neo Medical SA
Orthopedic · 80d
Cleared Oct 13, 2020
G21 Cement, VADER® Pedicle System
K200596
Icotec AG
Orthopedic · 221d
Cleared Aug 19, 2020
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
K201362
Medtronic
Orthopedic · 89d
Cleared Mar 31, 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818
Stryker Corporation
Orthopedic · 182d
Cleared Sep 19, 2019
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
K190526
CarboFix Orthopedics , Ltd.
Orthopedic · 199d
Cleared Sep 12, 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
K191148
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 135d
Cleared Nov 28, 2018
NuVasive Reline Fenestrated Screws, High V+ Bone Cement
K180498
Nu Vasive, Incorporated
Orthopedic · 275d
Cleared Mar 27, 2018
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
K172269
Globus Medical, Inc.
Orthopedic · 242d

About Product Code PML - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code PML since 2016, with 18 receiving FDA clearance (average review time: 147 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - PML Product Code

FDA review times for PML submissions have been consistent, averaging 134 days recently vs 148 days historically.

PML devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →