Atlas FDA

PML

19 FDA 510(k) clearances · Product code

134 daysmedian time to decision
265 days90th percentile
19clearances measured

FDA profile

Official device name
Bone Cement, Posterior Screw Augmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Medical specialty
Orthopedic
Flags
Implant
FDA definition
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Adverse events (MAUDE)
2020: 27 · 2021: 32 · 2023: 18 · 2024: 60 · 2025: 56 · 2026: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Dynamo™ Spinal Cement; Salvo® Spine System (K260286)Spine Wave, Inc.2026-06-15
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252885)Astura Medical2026-01-22
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (K241034)Medacta International S.A.2024-06-12
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (K231809)Ulrich Medical USA2023-10-20
PERLA® TL System; TEKTONA® HV US Bone Cement (K230774)Spineart2023-06-23
VADER® Pedicle System, G21 Cement (K222789)Icotec AG2023-01-09
Invictus® Bone Cement, Invictus Spinal Fixation System (K221926)Alphatec Spine, Inc.2022-12-20
BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (K222256)Neo Medical SA2022-08-26
BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489)Neo Medical SA2021-10-28
G21 Cement, VADER® Pedicle System (K200596)Icotec AG2020-10-13
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (K201362)Medtronic2020-08-19
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (K192818)Stryker Corporation2020-03-31
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526)CarboFix Orthopedics , Ltd.2019-09-19
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (K191148)Medtronic Sofamor Danek USA, Inc.2019-09-12
NuVasive Reline Fenestrated Screws, High V+ Bone Cement (K180498)Nu Vasive, Incorporated2018-11-28
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System (K172269)Globus Medical, Inc.2018-03-27
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set (K171938)Medtronic2017-10-23
CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (K160879)Medos International Sàrl2016-12-20
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (K152604)Medtronic Sofamor Danek USA, Incorporated2016-01-06

Track PML automatically

Every clearance here is in the API, with alerts when new ones post.