Atlas FDA

MQP

279 FDA 510(k) clearances · Product code

88 daysmedian time to decision
228 days90th percentile
279clearances measured

FDA profile

Official device name
Spinal Vertebral Body Replacement Device
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 208 · 2022: 137 · 2023: 71 · 2024: 100 · 2025: 170 · 2026: 104
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Vertiwedge® Intraosseous System (K261810)Foundation Surgical Group2026-07-31
POSEIDON ST (K261031)Signus Medinzintechnik GmbH2026-07-10
VyBrate™ VBR System (K253158)Vy Spine, LLC2026-01-07
Vertiwedge® Intraosseous System (K241468)Foundation Surgical Group, Inc.2024-11-07
KONG®-TL VBR System and KONG® C VBR System (K232790)Icotec AG2024-04-04
DOMINION Expandable Corpectomy System (K233359)Astura Medical2024-03-08
VerteLoc Spinal System (K231134)Signature Orthopaedics Pty, Ltd.2024-02-13
Ascend VBR System, Ascend NanoTec VBR System (K232173)Alphatec Spine, Inc.2023-10-06
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (K211892)Arftx Medical, LLC2022-10-06
F3D Corpectomy System (K202637)Corelink, LLC2020-12-23
KONG-TL VBR System, KONG-C VBR System (K200235)Icotec AG2020-05-29
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System (K193506)Nu Vasive, Incorporated2020-02-26
Small VBR™ (K192117)Ulrich GmbH & Co. KG2019-11-01
MediExpand TL Expandable VBR System (K190349)Cmf Medicon Surgical, Inc.2019-10-24
CarboClear VBR System (K192214)CarboFix Orthopedics , Ltd.2019-10-11
SYNMESH System (K183054)Depuy Synthes Spine2019-05-23
COLOSSEUM Mesh (K190147)Globus Medical, Inc.2019-05-08
PYRAMESH™ Implant System (K183197)Medtronic Sofamor Danek USA, Inc.2019-04-04
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (K183588)Choicespine2019-02-22
T2 STRATOSPHERE Expandable Corpectomy System (K183510)Medtronic Sofamor Danek USA, Inc.2019-01-16
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System (K180665)K2m, LLC2018-11-28
Solidity Vertebral Body Replacement (K181921)Ulrich Medical USA2018-11-16
FORTIFY Corpectomy Spacers (K173982)Globus Medical, Inc.2018-09-19
T2 STRATOSPHERE™ Expandable Corpectomy System (K181328)Medtronic Sofamor Danek USA, Inc.2018-09-19
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System (K173787)Medos International SARL2018-06-11
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage (K173800)Camber Spine Technologies2018-02-02
Blustone Synergy Silica System (K172330)Blustone Synergy2017-12-21
T2 STRATOSPHERE™ Expandable Corpectomy System (K173125)Medtronic Sofamor Danek2017-12-20
FORTIFY Corpectomy Spacers (K162315)Globus Medical, Inc.2017-11-09
Omnia Medical VBR (K172323)Omnia Medical, LLC2017-10-26
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (K171686)Choicespine2017-09-15
CAPRI Corpectomy Cage System (K171704)K2m2017-08-31
VerteFIT Corpectomy Cage System (K162133)Ldr Spine USA, Inc.2017-05-16
CAPRI Corpectomy Cage System (K170055)K2m2017-04-13
NuVasive(r) Monolith Corpectomy System (K170271)Nu Vasive, Incorporated2017-03-30
Rectangular Corpectomy Cage (K152460)Amendia, Inc.2015-12-22
NuVasive PEEK Corpectomy Railed System (K151538)Nu Vasive, Incorporated2015-09-04
NuVasive PEEK Corpectomy System (K151167)Nu Vasive, Incorporated2015-09-03
SpineFab Vertebral Body Replacement (VBR) System (K142005)Oxford Performance Materials2015-07-10
NuVasive X-CORE(R) Expandable VBR System (K142205)Nuvasive, Inc.2015-02-20
StaXx(R) XD System (K142996)Spine Wave, Inc.2015-02-19
VERTA Corpectomy Cage (K143490)Camber Spine2015-01-26
STGC-LORDOTIC (K142030)Cardinal Spine, LLC2015-01-23
CAPRI (K142016)K2m, Inc.2014-11-06
AIS MODULIFT VBR SYSTEM (K142150)Aesculap Implant System, Inc.2014-10-29
LATERAL VBR SYSTEM (K140563)Nu Vasive, Incorporated2014-08-07
AIS MODULIFT VBR SYSTEM (K133802)Aesculap Implant System, Inc.2014-04-17
TASMIN R (K123758)Signus Medizintechnik GmbH2014-01-14
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (K131724)Pioneer Surgical Technology, Inc.2013-12-24
STAXX(R) SYSTEM (K133207)Spine Wave, Inc.2013-12-06
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE (K131888)Medtronic Sofamor Danek, Inc.2013-09-23
ENDURAMESH (K122622)Lucero Medical, LLC2012-09-19
STAXX XD SYSTEM (K121889)Spine Wave, Inc.2012-08-29
STGC (K121176)Cardinal Spine, LLC2012-08-17
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) (K121107)Globus Medical, Inc.2012-07-03
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM (K120570)Choicespine, LP2012-04-05
SANTORINI SPINAL SYSTEM (K111294)K2m, Inc.2012-01-27
GIZA(R) VERTEBRAL BODY REPLACEMENT (K112429)Eden Spine, LLC2012-01-26
STAXX(R) XD SYSTEM (K111418)Spine Wave, Inc.2011-12-13
SYNTHES XRL (K103320)Synthes Spine Co.Lp2011-10-20
SFC VERTEBRAL BODY REPLACEMENT (K110153)Konigsee Implantate GmbH2011-10-12
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS (K112756)Globus Medical, Inc.2011-10-07
STAXX XDL SYSTEM (K102315)Spine Wave, Inc.2011-08-19
DSC/ALF SPINAL SYSTEM (K101886)Sintea Plastek, LLC2011-07-21
STAXXSD SYSTEM (K111469)Spine Wave, Inc.2011-07-19
BIOSPINE VBR SYSTEM (K110864)Aesculap Implant Systems, LLC2011-06-15
STAXX(R) XD SYSTEM (K102682)Spine Wave, Inc.2010-11-30
T2 XVBR 1.5 SPINAL SYSTEM (K100976)Medtronic Sofamor Danek USA, Inc.2010-10-21
STAXX XD SYSTEM (K101288)Spine Wave, Inc.2010-09-10
ENDURAMESH, MODEL 762.XXX (K093207)Lucero Medical, LLC2010-04-26
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET (K093127)Zimmer Trabecular Metal Technology2010-03-04
AESCULAP HYDROLIFT VBR SYSTEM (K083186)Aesculap Implant System, Inc.2010-03-04
CERVICORE CORPECTOMY CAGE (K091426)Verticor, Ltd.2009-12-23
SEC VBR (K091743)Innvotec Surgical, Inc.2009-11-02
C-THRU SPINAL SYSTEM (K092336)Ebi, L.P.2009-10-15
ADDPLUS (K090841)Ulrich GmbH & Co. KG2009-10-05
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX (K091946)Stryker Spine2009-09-25
T2 SPINAL SYSTEM (K091883)Medtronic Sofamor Danek USA, Inc.2009-09-21
ATLAS SPINE SPACER (K091406)Atlas Spine, LLC2009-09-04
STAXX XD SYSTEM (K090315)Spine Wave, Inc.2009-09-03
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM (K090176)Nuvasive, Inc.2009-04-27
LDR SPINE ROI-C IMPLANT (K083857)Ldr Spine USA2009-02-12
XYCOR SPINAL IMPLANT (K082466)Vertebration,Inc2009-01-09
T2 XVBR SPINAL SYSTEM (K082112)Medtronic Sofamor Danek2008-08-27
RELIANCE VBS SYSTEM (K081383)Reliance Medical Systems, LLC2008-07-02
SPINESMITH CIMPLICITY SPINAL SYSTEM (K080971)Spine Smith Partners L.P.2008-07-02
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION (K081564)Creaspine2008-06-30
OSTAPEK VBR SYSTEM (K072326)Co-Ligne AG2008-06-24
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM (K081332)Signus Medizintechnik GmbH2008-06-10
LDR SPINE ROI-C IMPLANT (K080728)Ldr Spine USA2008-05-29
CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM (K080860)Creaspine2008-05-29
NOVEL SPINAL SPACER SYSTEM (K080699)Alphatec Spine, Inc.2008-05-21
LDR SPINE ROI-T IMPLANT (K080569)Ldr Spine USA2008-05-07
X-MESH EXPANDABLE CAGE SYSTEM (K080568)Depuy Spine, Inc.2008-05-01
LDR SPINE ROI-A IMPLANT (K080572)Ldr Spine USA2008-04-07
VERTEBRON VBR SYSTEM (K073502)Vertebron, Inc.2008-03-24
KIMBA MINI (K080349)Signus Medizintechnik GmbH2008-03-10
BENGAL STACKABLE CAGE SYSTEM (K073649)Depuy Spine, Inc.2008-01-25
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 (K080024)K2m, Inc.2008-01-24
MODIFICATION TO VALEO VBR (K073505)Amedica Corp.2008-01-09
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Every clearance here is in the API, with alerts when new ones post.