Atlas FDA

MAX

895 FDA 510(k) clearances · Product code

106 daysmedian time to decision
261 days90th percentile
895clearances measured

FDA profile

Official device name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3080
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Adverse events (MAUDE)
2021: 622 · 2022: 618 · 2023: 576 · 2024: 729 · 2025: 826 · 2026: 412
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TruLift Expandable System (K261430)Life Spine, Inc.2026-07-28
Catalyft PL Expandable Interbody System (K253011)Medtronic Sofamor Danek USA, Inc.2026-07-17
Symmetrix™ L Spinal System (K261020)Medtronic Sofamor Danek USA, Inc.2026-07-14
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (K253420)SeaSpine Orthopedics Corporation2026-07-01
Fule Interbody Fusion Cage System (K253151)Beijing Fule Science & Technology Development Co., Ltd.2026-06-15
Exceed® Biplanar Expandable Interbody System (K261159)Spine Wave, Inc.2026-05-29
BMD Titanium Spinal Fusion System (K253894)Global Biomedica s.r.o.2026-05-28
Ventana® P/T Lumbar Interbody System (K260506)Spinal Elements, Inc.2026-05-15
VersaLift Expandable System (K260837)Life Spine, Inc.2026-05-12
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (K260385)Carlsmed, Inc.2026-05-09
BEE PLIF Cage (K261067)NGMedical GmbH2026-04-30
SWINGO-3D Lumbar Cage System (K254017)Implanet2026-02-26
LUX Expandable Lumbar Interbody System (K253583)Xenix Medical2026-02-23
Luna® Ti Interbody Fusion System (K250773)Spinal Elements, Inc.2026-02-04
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (K253748)Life Spine, Inc.2026-01-23
Titanium Interbody System (K253266)Spine Innovation, LLC2026-01-08
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (K253577)Medicrea International S.A.S. (Medtronic)2025-12-19
ZSFab Lumbar Interbody System (K252610)Zsfab, Inc.2025-11-25
UniSpace® TPLIF Cage (K252351)Cg Medtech Co., Ltd.2025-10-28
Expandable Titanium PLIF/TLIF System (K253377)Spectrum Spine, Inc.2025-10-24
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) (K251479)Mobarn Medical Devices, LLC2025-09-18
Endoskeleton™ Interbody Systems (K251444)Medtronic Sofamor Danek USA, Inc.2025-09-04
Atlas Spine Project X Expandable Posterior Lumbar Interbody System (K251969)Atlas Spine, Inc.2025-08-15
PRADO™ Lumbar Interbody Fusion System (K252113)Bethesda Medical Devices2025-08-05
MectaLIF 3D Metal (K251016)Medacta International S.A.2025-07-17
PathLoc Lumbar Interbody Fusion Cage System (K251741)L&K BIOMED Co., Ltd.2025-07-08
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (K251502)Life Spine, Inc.2025-07-07
aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (K250827)Carlsmed, Inc.2025-07-07
aprevo® posterior/transforaminal lumbar interbody fusion device (K250987)Carlsmed, Inc.2025-06-30
Testa TP Pivoting Spacer System (K243816)Spine Wave, Inc.2025-06-27
X-PAC® LLIF Expandable Lateral Cage System (K251003)Expanding Innovations, Inc.2025-06-25
X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (K251617)Expanding Innovations, Inc.2025-06-16
FIX-L PEEK PLIF and T-PLIF System (K243973)Jeil Medical Corporation2025-06-12
Tera Lumbar Interbody Fusion System (Various PNs) (K251335)Acuity Surgical Devices, LLC2025-06-02
FlareHawk Interbody Fusion System (K243116)Integrity Implants Inc. Dba Accelus2025-05-21
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K250669)Medtronic Sofamor Danek USA, Inc.2025-04-22
ProLift Expandable Spacer System (K250373)Life Spine, Inc.2025-04-09
Spectrum Spine Lumbar Cage System (K243074)Spectrum Spine, Inc.2025-04-04
DeGen Medical Patient Specific Implant (PSI) System (K250667)Degen Medical2025-04-04
GoLIF! Lumbar Interbody Fusion System (K250186)Getset Surgical, SA2025-03-21
Tesera-k PL System and Tesera-k XL System (K242771)Kyocera Medical Technologies, Inc.2025-03-20
FortiVy™ OsteoVy™ Lumbar IBF (K241783)Vy Spine, LLC2025-03-18
IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (K241375)Alphatec Spine2025-02-03
AxCess® Expandable Interbody System (K243739)Elliquence, LLC2025-01-24
ProLift Pivot Expandable Spacer System (K243668)Life Spine, Inc.2025-01-23
Idys® LIF (K243670)Clariance2024-12-31
DZ-Tabone Intervertebral Body Fusion Device (K241073)Shenzhen Dazhou Medical Technology Co., Ltd.2024-12-06
BluEX Lumbar Expandable Cage System (K242829)L&K BIOMED Co., Ltd.2024-10-23
Scarlet® AL-T (K242589)Spineart SA2024-10-23
KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (K233947)Ctl Medical Corporation2024-10-10
Gemini Medical Cage System (K242267)ZheJiang Decans Medical Devices Co., Ltd.2024-10-08
ProLift Wedge Expandable Spacer System (K242826)Life Spine, Inc.2024-10-08
EARP Interbody System (K242457)Retropsoas Technologies, LLC2024-10-07
IdentiTi™ II Interbody System (K242364)Alphatec Spine, Inc.2024-10-04
ARTFX Lumbar PEEK Cages (K240889)Artfx Medical2024-10-02
LumiVy™ Lumbar IBF System (K233807)Vy Spine, LLC2024-09-24
aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (K241332)Carlsmed, Inc.2024-09-20
Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (K242147)Alphatec Spine, Inc.2024-09-20
HAnano InterFuse(R) Modular Interbody (K242509)Next Orthosurgical2024-09-19
3D Printed PEEK Interbody System (K240250)Nvision Biomedical Technologies, Inc.2024-09-17
Signus Tetris™ St; Signus Tetris™ R St (K241438)Signus Medizintechnik GmbH2024-09-11
IB3D™ PL Spinal System (K241164)Medicrea International S.A.S. (Medtronic)2024-09-06
Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) (K232996)Shanghai Iatrical-Ti Technologies CO , Ltd.2024-09-06
COSINE™ Spacer (K234035)Globus Medical, Inc.2024-09-06
Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology (K241605)Nanovis, LLC2024-09-05
aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) (K241328)Carlsmed, Inc.2024-08-12
Solar™ Lumbar Interbody Fusion System (K240326)Degen Medical, Inc.2024-07-29
sagAlign Lumbar Cage System (Various PNs) (K241413)Acuity Surgical Devices, LLC2024-07-17
SPIRA® Anterior Lumbar Spacers (K234077)Camber Spine Technologies2024-07-12
aprevo® TLIF-C Articulating System (K241019)Carlsmed2024-07-09
Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System (K241466)SeaSpine Orthopedics Corporation2024-06-20
Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (K240830)Orthofix Medical, Inc.2024-06-20
PILLAR SA Ti Spacer System (82-XXX) (K240749)Orthofix, Inc.2024-05-28
Reef L Interbody System; WaveForm L Interbody System (K240566)SeaSpine Orthopedics Corporation2024-04-26
Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (K233509)Zavation Medical Products, LLC2024-04-10
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (K232792)Icotec AG2024-04-05
Lucent® XP (K234150)Spinal Elements2024-03-27
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device (K232282)Carlsmed, Inc.2024-03-22
Tranquil-L Interbody System (K233375)Nexus Spine, LLC2024-03-20
“BioGend” Interbody Fusion System 001 Cage (K233075)Biogend Therapeutics Co., Ltd.2024-03-06
restor3d TIDAL Lumbar Interbody Fusion System (K234087)Restor3D2024-01-22
Curiteva Porous PEEK Lumbar Interbody Fusion System (K233744)Curiteva, Inc.2024-01-18
Meridian Interbody System; WaveForm A Interbody System (K233694)SeaSpine Orthopedics Corporation2024-01-12
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (K230872)Shanghai Sanyou Medical Co, Ltd.2023-12-12
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (K231743)Corelink, LLC2023-12-08
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System (K232611)Life Spine, Inc.2023-11-30
Expandable Lumbar Fusion Cage (Type I,Type II) (K232069)Shanghai Reach Medical Instrument Co, Ltd.2023-11-29
Peridot-EX Expandable Intervertebral Body Fusion System (K232292)Gbs Commonwealth Co., Ltd.2023-11-07
Calibrate CCX Interbody System (K232504)Alphatec Spine, Inc.2023-10-13
CONDUIT™ ATP Inserters (K232014)Enztec Limited2023-09-01
AccelFix Lumbar Expandable Cage System (K231680)L&K BIOMED Co., Ltd.2023-08-24
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (K221894)Globus Medical, Inc.2023-08-03
Exceed™ Biplanar Expandable Interbody System (K231275)Spine Wave, Inc.2023-07-25
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (K231438)Alphatec Spine, Inc.2023-07-13
NanoHive Medical Lumbar Interbody System (K231241)NanoHive Medical, LLC2023-07-12
SPIRA® Posterior Lumbar Spacers (K230942)Camber Spine Technologies2023-07-11
Ventana™ L Spinal System (K231252)Spinal Elements, Inc.2023-06-30
Solar Lumbar Interbody Fusion System (K231199)Degen Medical2023-06-16
RODIN™ Expandable Lumbar Cage System (K231359)Ctl Medical Corporation2023-06-09
Kodiak Lumbar Spacer System (K230851)Met One Technologies, LLC2023-05-26
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Every clearance here is in the API, with alerts when new ones post.