Intervertebral Fusion Device With Bone Graft, Lumbar
FDA product code MAX · Class II (moderate risk) · 21 CFR 888.3080 · Orthopedic
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
896510(k) clearances
6PMA approvals
113recalls
Implantimplanted device
Manufacturers
- Medtronic Sofamor Danek USA, Inc. 37
- Nu Vasive, Incorporated 34
- Life Spine, Inc. 33
- Spineology, Inc. 22
- Alphatec Spine, Inc. 21
- SeaSpine Orthopedics Corporation 20
- Globus Medical, Inc. 20
- Medtronic Sofamor Danek 18
- Spinal Elements, Inc. 17
- Stryker Corporation 17
- Spine Wave, Inc. 14
- K2m, Inc. 13
- Spineart 12
- L&K BIOMED Co., Ltd. 11
- Medos International SARL 11
- Carlsmed, Inc. 11
- Zavation Medical Products, LLC 9
- Coalign Innovations, Inc. 9
- Pinnacle Spine Group, LLC 8
- Genesys Spine 8
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…MAX · Traditional | Carlsmed, Inc. | 05/09/2026SE |
| K261067 | BEE PLIF CageMAX · Special | NGMedical GmbH | 04/30/2026SE |
| K254017 | SWINGO-3D Lumbar Cage SystemMAX · Traditional | Implanet | 02/26/2026SE |
| K253583 | LUX Expandable Lumbar Interbody SystemMAX · Traditional | Xenix Medical | 02/23/2026SE |
| K250773 | Luna® Ti Interbody Fusion SystemMAX · Traditional | Spinal Elements, Inc. | 02/04/2026SE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 01/23/2026SE |
| K253266 | Titanium Interbody SystemMAX · Special | Spine Innovation, LLC | 01/08/2026SE |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)MAX · Special | Medicrea International S.A.S. (Medtronic) | 12/19/2025SE |
| K252610 | ZSFab Lumbar Interbody SystemMAX · Special | Zsfab, Inc. | 11/25/2025SE |
| K252351 | UniSpace® TPLIF CageMAX · Traditional | Cg Medtech Co., Ltd. | 10/28/2025SE |
| K253377 | Expandable Titanium PLIF/TLIF SystemMAX · Special | Spectrum Spine, Inc. | 10/24/2025SE |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…MAX · Traditional | Mobarn Medical Devices, LLC | 09/18/2025SE |
| K251444 | Endoskeleton Interbody SystemsMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 09/04/2025SE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemMAX · Traditional | Atlas Spine, Inc. | 08/15/2025SE |
| K252113 | PRADO Lumbar Interbody Fusion SystemMAX · Special | Bethesda Medical Devices | 08/05/2025SE |
| K251016 | MectaLIF 3D MetalMAX · Traditional | Medacta International S.A. | 07/17/2025SE |
| K251741 | PathLoc Lumbar Interbody Fusion Cage SystemMAX · Special | L&K BIOMED Co., Ltd. | 07/08/2025SE |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemMAX · Traditional | Life Spine, Inc. | 07/07/2025SE |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…MAX · Traditional | Carlsmed, Inc. | 07/07/2025SE |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion deviceMAX · Traditional | Carlsmed, Inc. | 06/30/2025SE |
| K243816 | Testa TP Pivoting Spacer SystemMAX · Traditional | Spine Wave, Inc. | 06/27/2025SE |
| K251003 | X-PAC® LLIF Expandable Lateral Cage SystemMAX · Traditional | Expanding Innovations, Inc. | 06/25/2025SE |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemMAX · Special | Expanding Innovations, Inc. | 06/16/2025SE |
| K243973 | FIX-L PEEK PLIF and T-PLIF SystemMAX · Traditional | Jeil Medical Corporation | 06/12/2025SE |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs)MAX · Traditional | Acuity Surgical Devices, LLC | 06/02/2025SE |
| K243116 | FlareHawk Interbody Fusion SystemMAX · Traditional | Integrity Implants Inc. Dba Accelus | 05/21/2025SE |
| K250669 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 04/22/2025SE |
| K250373 | ProLift Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 04/09/2025SE |
| K250667 | DeGen Medical Patient Specific Implant (PSI) SystemMAX · Special | Degen Medical | 04/04/2025SE |
| K243074 | Spectrum Spine Lumbar Cage SystemMAX · Traditional | Spectrum Spine, Inc. | 04/04/2025SE |
| K250186 | GoLIF! Lumbar Interbody Fusion SystemMAX · Traditional | Getset Surgical, SA | 03/21/2025SE |
| K242771 | Tesera-k PL System and Tesera-k XL SystemMAX · Traditional | Kyocera Medical Technologies, Inc. | 03/20/2025SE |
| K241783 | FortiVy OsteoVy Lumbar IBFMAX · Traditional | Vy Spine, LLC | 03/18/2025SE |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional | Alphatec Spine | 02/03/2025SE |
| K243739 | AxCess® Expandable Interbody SystemMAX · Traditional | Elliquence, LLC | 01/24/2025SE |
| K243668 | ProLift Pivot Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 01/23/2025SE |
| K243670 | Idys® LIFMAX · Special | Clariance | 12/31/2024SE |
| K241073 | DZ-Tabone Intervertebral Body Fusion DeviceMAX · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 12/06/2024SE |
| K242829 | BluEX Lumbar Expandable Cage SystemMAX · Traditional | L&K BIOMED Co., Ltd. | 10/23/2024SE |
| K242589 | Scarlet® AL-TMAX · Traditional | Spineart SA | 10/23/2024SE |
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage SystemMAX · Traditional | Ctl Medical Corporation | 10/10/2024SE |
| K242826 | ProLift Wedge Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 10/08/2024SE |
| K242267 | Gemini Medical Cage SystemMAX · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 10/08/2024SE |
| K242457 | EARP Interbody SystemMAX · Special | Retropsoas Technologies, LLC | 10/07/2024SE |
| K242364 | IdentiTi II Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 10/04/2024SE |
| K240889 | ARTFX Lumbar PEEK CagesMAX · Traditional | Artfx Medical | 10/02/2024SE |
| K233807 | LumiVy Lumbar IBF SystemMAX · Traditional | Vy Spine, LLC | 09/24/2024SE |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 09/20/2024SE |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…MAX · Traditional | Carlsmed, Inc. | 09/20/2024SE |
| K242509 | HAnano InterFuse(R) Modular InterbodyMAX · Special | Next Orthosurgical | 09/19/2024SE |
| K240250 | 3D Printed PEEK Interbody SystemMAX · Traditional | Nvision Biomedical Technologies, Inc. | 09/17/2024SE |
| K241438 | Signus Tetris St; Signus Tetris R StMAX · Traditional | Signus Medizintechnik GmbH | 09/11/2024SE |
| K241164 | IB3D PL Spinal SystemMAX · Traditional | Medicrea International S.A.S. (Medtronic) | 09/06/2024SE |
| K234035 | COSINE SpacerMAX · Traditional | Globus Medical, Inc. | 09/06/2024SE |
| K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)MAX · Traditional | Shanghai Iatrical-Ti Technologies CO , Ltd. | 09/06/2024SE |
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System…MAX · Traditional | Nanovis, LLC | 09/05/2024SE |
| K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…MAX · Traditional | Carlsmed, Inc. | 08/12/2024SE |
| K240326 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | Degen Medical, Inc. | 07/29/2024SE |
| K241413 | sagAlign Lumbar Cage System (Various PNs)MAX · Traditional | Acuity Surgical Devices, LLC | 07/17/2024SE |
| K234077 | SPIRA® Anterior Lumbar SpacersMAX · Traditional | Camber Spine Technologies | 07/12/2024SE |
| K241019 | aprevo® TLIF-C Articulating SystemMAX · Traditional | Carlsmed | 07/09/2024SE |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…MAX · Special | SeaSpine Orthopedics Corporation | 06/20/2024SE |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…MAX · Traditional | Orthofix Medical, Inc. | 06/20/2024SE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX)MAX · Traditional | Orthofix, Inc. | 05/28/2024SE |
| K240566 | Reef L Interbody System; WaveForm L Interbody SystemMAX · Traditional | SeaSpine Orthopedics Corporation | 04/26/2024SE |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…MAX · Traditional | Zavation Medical Products, LLC | 04/10/2024SE |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…MAX · Traditional | Icotec AG | 04/05/2024SE |
| K234150 | Lucent® XPMAX · Traditional | Spinal Elements | 03/27/2024SE |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…MAX · Traditional | Carlsmed, Inc. | 03/22/2024SE |
| K233375 | Tranquil-L Interbody SystemMAX · Special | Nexus Spine, LLC | 03/20/2024SE |
| K233075 | BioGend Interbody Fusion System 001 CageMAX · Traditional | Biogend Therapeutics Co., Ltd. | 03/06/2024SE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion SystemMAX · Special | Restor3D | 01/22/2024SE |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAX · Traditional | Curiteva, Inc. | 01/18/2024SE |
| K233694 | Meridian Interbody System; WaveForm A Interbody SystemMAX · Traditional | SeaSpine Orthopedics Corporation | 01/12/2024SE |
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction…MAX · Traditional | Shanghai Sanyou Medical Co, Ltd. | 12/12/2023SE |
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…MAX · Traditional | Corelink, LLC | 12/08/2023SE |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 11/30/2023SE |
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II)MAX · Traditional | Shanghai Reach Medical Instrument Co, Ltd. | 11/29/2023SE |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion SystemMAX · Traditional | Gbs Commonwealth Co., Ltd. | 11/07/2023SE |
| K232504 | Calibrate CCX Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 10/13/2023SE |
| K232014 | CONDUIT ATP InsertersMAX · Special | Enztec Limited | 09/01/2023SE |
| K231680 | AccelFix Lumbar Expandable Cage SystemMAX · Special | L&K BIOMED Co., Ltd. | 08/24/2023SE |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsMAX · Traditional | Globus Medical, Inc. | 08/03/2023SE |
| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 07/25/2023SE |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 07/13/2023SE |
| K231241 | NanoHive Medical Lumbar Interbody SystemMAX · Traditional | NanoHive Medical, LLC | 07/12/2023SE |
| K230942 | SPIRA® Posterior Lumbar SpacersMAX · Traditional | Camber Spine Technologies | 07/11/2023SE |
| K231252 | Ventana L Spinal SystemMAX · Traditional | Spinal Elements, Inc. | 06/30/2023SE |
| K231199 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | Degen Medical | 06/16/2023SE |
| K231359 | RODIN Expandable Lumbar Cage SystemMAX · Special | Ctl Medical Corporation | 06/09/2023SE |
| K230851 | Kodiak Lumbar Spacer SystemMAX · Traditional | Met One Technologies, LLC | 05/26/2023SE |
| K231140 | aprevo® transforaminal lumbar interbody fusion deviceMAX · Special | Carlsmed, Inc. | 05/19/2023SE |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsMAX · Traditional | Eminent Spine, LLC | 05/16/2023SE |
| K223335 | SIRION Lateral Lumbar Interbody SystemMAX · Traditional | Astura Medical | 05/09/2023SE |
| K223430 | ProLift Micro Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 05/04/2023SE |
| K223868 | PYXIS 3D Titanium Cage SystemMAX · Traditional | GS Medical Co., Ltd. | 04/26/2023SE |
| K223611 | Calibrate LTX Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 03/29/2023SE |
| K223418 | DeGen Impulse AM SystemMAX · Traditional | Degen Medical | 03/17/2023SE |
| K223688 | CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT InstrumentsMAX · Traditional | Medos International Sàrl | 03/08/2023SE |
| K223776 | PEEK Spinal Infusion CageMAX · Traditional | Changzhou Geasure Medical Apparatus and… | 03/03/2023SE |
| K223174 | X-Pac Expandable LLIF Cage SystemMAX · Traditional | Expanding Innovations, Inc. | 02/14/2023SE |
| K223474 | PathLoc-TA Expandable Lumbar Cage SystemMAX · Traditional | L&K BIOMED Co., Ltd. | 01/13/2023SE |
| K223412 | LumiVy Lumbar IBF SystemMAX · Special | Vy Spine, LLC | 01/06/2023SE |
| K223671 | CONDUIT LLIF Straight InsertersMAX · Special | Enztec Limited | 01/05/2023SE |
| K223654 | Medussa-PL CageMAX · Special | Medyssey USA, Inc. | 12/28/2022SE |
| K213653 | 4CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemMAX · Traditional | Solco Biomedical Company India Private Limited | 12/19/2022SE |
| K223251 | Hexanium PLIFMAX · Traditional | Spinevision, S.A.S. | 12/16/2022SE |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 12/16/2022SE |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF)MAX · Traditional | Southern Medical (Pty) , Ltd. | 12/08/2022SE |
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate SystemMAX · Traditional | Life Spine, Inc. | 12/05/2022SE |
| K222455 | Calibrate LTX Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 11/18/2022SE |
| K222732 | WaveForm A Interbody SystemMAX · Traditional | SeaSpine Orthopedics Corporation | 11/07/2022SE |
| K221719 | ABTross ALIF Expandable Cage SystemMAX · Traditional | Aegis Spine, Inc. | 11/03/2022SE |
| K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesMAX · Special | Adcura, Inc. | 10/26/2022SE |
| K222203 | DualXSLIM(R) T/PLIFMAX · Traditional | Amplify Surgical, Inc. | 10/18/2022SE |
| K222797 | X-Pac Expandable Lumbar Cage SystemMAX · Special | Expanding Innovations, Inc. | 10/14/2022SE |
| K221858 | ZSFab Lumbar Interbody SystemMAX · Traditional | Zsfab, Inc. | 10/14/2022SE |
| K221172 | FOCUS Interbody SystemMAX · Traditional | Oc Medical Devices | 10/14/2022SE |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend…MAX · Traditional | Alphatec Spine | 10/07/2022SE |
| K213417 | Ghost Spacer SystemMAX · Traditional | Life Spine, Inc. | 09/29/2022SE |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation PlateMAX · Traditional | Ctl Medical Corporation | 09/15/2022SE |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody SystemMAX · Traditional | Choice Spine, LLC | 09/13/2022SE |
| K221325 | CONDUIT Lateral Switch PlateMAX · Traditional | Medos International SARL | 08/25/2022SE |
| K221844 | TDM Lumbar Interbody Fusion Cage SystemMAX · Traditional | Tdm Co., Ltd. | 08/17/2022SE |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…MAX · Special | Carlsmed, Inc. | 08/12/2022SE |
| K221687 | Pegasus-X Expandable PLIF SystemMAX · Traditional | GS Medical Co., Ltd. | 07/27/2022SE |
| K221535 | Align Lumbar Interbody Fusion SystemMAX · Traditional | Acuity Surgical Devices, LLC | 07/22/2022SE |
| K220449 | DePuy CONDUIT LLIF SQUID InserterMAX · Traditional | Enztec Limited | 06/28/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | Nu Vasive, Incorporated | 06/21/2022SE |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion DeviceMAX · Traditional | Restor3D | 06/17/2022SE |
| K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend…MAX · Traditional | Alphatec Spine, Inc. | 06/09/2022SE |
| K220581 | Zavation eZspand Interbody SystemMAX · Traditional | Zavation Medical Products, LLC | 06/02/2022SE |
| K220902 | Navagio Lumbar CageMAX · Traditional | Kalitec Medical, LLC | 05/27/2022SE |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemMAX · Traditional | SeaSpine Orthopedics Corporation | 05/10/2022SE |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA SystemMAX · Traditional | SeaSpine Orthopedics Corporation | 05/04/2022SE |
| K212477 | EARP Interbody SystemMAX · Traditional | Nvision Biomedical Technologies, Inc. | 04/28/2022SE |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMAX · Traditional | Medtronic Sofamor Danek USA | 04/12/2022SE |
| K212811 | Ti3Z Lumbar Interbody SystemMAX · Traditional | Zavation Medical Products, LLC | 04/12/2022SE |
| K213355 | Toro-L Interbody Fusion SystemMAX · Traditional | Integrity Implants, Inc. | 03/25/2022SE |
| K220655 | X-Pac Expandable Lumbar Cage SystemMAX · Special | Expanding Innovations, Inc. | 03/24/2022SE |
| K220453 | FlareHawk Interbody Fusion SystemMAX · Special | Integrity Implants, Inc. | 03/24/2022SE |
| K220096 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Special | Genesys Spine | 03/09/2022SE |
| K213441 | PathLoc Lumbar Interbody Fusion Cage SystemMAX · Traditional | L&K BIOMED Co., Ltd. | 03/09/2022SE |
| K212930 | LumiVy Lumbar IBF SystemMAX · Traditional | Vy Spine, LLC | 02/16/2022SE |
| K213951 | FORZA XP Expandable Spacer SystemMAX · Special | Orthofix US, LLC | 01/05/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | Nu Vasive, Incorporated | 12/23/2021SE |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 12/08/2021SE |
| K212075 | ShurFit Lumbar Interbody SystemMAX · Traditional | Precision Spine, Inc. | 12/08/2021SE |
| K212050 | NGM WAVE PLIF CageMAX · Traditional | NGMedical GmbH | 12/01/2021SE |
| K212653 | Catalyft LS Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 11/19/2021SE |
| K211845 | Deploy Expandable Interbody SystemMAX · Traditional | Southern Spine, LLC | 11/16/2021SE |
| K212823 | DePuy CONDUIT LLIF Angled InsertersMAX · Traditional | Enztec Limited | 11/01/2021SE |
| K212831 | MectaLIF ExtensionMAX · Traditional | Medacta International S.A. | 10/29/2021SE |
| K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFMAX · Traditional | Intelivation, LLC | 10/29/2021SE |
| K212520 | ProLift Micro Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 10/08/2021SE |
| K211740 | DualXMAX · Special | Amplify Surgical, Inc. | 09/29/2021SE |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…MAX · Traditional | Alphatec Spine, Inc. | 09/22/2021SE |
| K211689 | KEYSTONE PEEK Cage SystemMAX · Traditional | Shanghai Sanyou Medical Co, Ltd. | 09/21/2021SE |
| K211474 | Kleiner KG2 SystemMAX · Traditional | BAAT Medical Products B.V. | 09/14/2021SE |
| K212540 | Explorer TO SystemMAX · Special | SeaSpine Orthopedics Corporation | 09/10/2021SE |
| K203014 | EndoLIF Delta-Cage and DoubleWedge-CageMAX · Traditional | Joimax GmbH | 09/01/2021SE |
| K212070 | KMTI S141 Lumbar Interbody Fusion SystemMAX · Special | Kyocera Medical Technologies, Inc. | 08/30/2021SE |
| K210090 | Impulse AM Interbody Fusion SystemMAX · Traditional | Degen Medical | 08/30/2021SE |
| K211413 | BEE PLIF CageMAX · Traditional | NGMedical GmbH | 08/27/2021SE |
| K210800 | IO Expandable Lumbar Interbody Fusion SystemMAX · Traditional | MiRus, LLC | 08/20/2021SE |
| K211873 | PSX Interbody SystemMAX · Traditional | Alphatec Spine, Inc. | 08/10/2021SE |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion DeviceMAX · Special | 4Web Medical, Inc. | 08/05/2021SE |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…MAX · Special | SeaSpine Orthopedics Corporation | 07/07/2021SE |
| K203003 | Pantheon IBFDMAX · Special | Pantheon Spinal | 07/07/2021SE |
| K210542 | aprevo Transforaminal IBFMAX · Traditional | Carlsmed, Inc. | 06/30/2021SE |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…MAX · Traditional | Spinal Elements, Inc. | 06/30/2021SE |
| K211306 | LabyrinthMAX · Traditional | Zavation Medical Products, LLC | 06/24/2021SE |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional | Camber Spine Technologies, LLC | 06/15/2021SE |
| K203802 | X-Pac Expandable Lumbar Cage SystemMAX · Traditional | Expanding Innovations, Inc. | 06/07/2021SE |
| K210583 | SeaSpine WaveForm A Interbody SystemMAX · Traditional | SeaSpine Orthopedics Corporation | 06/02/2021SE |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…MAX · Special | Medtronic Sofamor Danek USA, Inc. | 05/26/2021SE |
| K210425 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 05/24/2021SE |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemMAX · Traditional | Nu Vasive, Incorporated | 05/24/2021SE |
| K210439 | NuVasive MOD-EX XLIF Interbody SystemMAX · Traditional | Nu Vasive, Incorporated | 05/12/2021SE |
| K210728 | CONDUIT InstrumentsMAX · Traditional | Medos International SARL | 05/06/2021SE |
| K210061 | ProLift Lateral HELO FixatedMAX · Traditional | Life Spine, Inc. | 04/30/2021SE |
| K201024 | Expandable Titanium PLIF/TLIF SystemMAX · Traditional | Spectrum Spine, LLC | 04/29/2021SE |
| K200919 | Idys ALIF 3DTiMAX · Traditional | Clariance | 04/12/2021SE |
| K203254 | Lucent 3D Spinal SystemMAX · Traditional | Spinal Elements, Inc. | 03/26/2021SE |
| K203038 | Toro-L Interbody Fusion SystemMAX · Traditional | Integrity Implants, Inc. | 03/26/2021SE |
| K203361 | ProLift Wedge Expandable Spacer SystemMAX · Traditional | Life Spine, Inc. | 03/17/2021SE |
| K210359 | Hexanium TLIFMAX · Special | Spinevision, S.A.S. | 03/10/2021SE |
| K203576 | FORZA Ti Spacer SystemMAX · Traditional | Orthofix, Inc. | 03/03/2021SE |
| K210155 | Duo Expandable Interbody Fusion SystemMAX · Special | Spineology, Inc. | 02/19/2021SE |
| K202380 | Born PT-LIF Cage HAMAX · Traditional | Spineworxx AG | 02/19/2021SE |
PMA approvals
- P000028 Affinity (TM) Cage System · Medtronic Sofamor Danek USA, Inc. · 06/13/2002
- P980048 Bak/Cervical (Bak/C) Interbody Fusion System · Sulzer Spine-Tech · 04/20/2001
- P970015 Inter Fix Threaded Fusion Device · Sofamor Danek · 05/14/1999
- P960025 Brantigen I/F Cage(R) Used with Vsp(R) Spine Plates and Pedicle Screws · Depuy Spine, Inc. · 02/02/1999
- P950019 Ray Threaded Fusion Cage (Tfc)(Tm) with Instrumentation · Stryker Spine · 10/29/1996
- P950002 Bak Interbody Fusion System · Zimmer Spine, Inc. · 09/20/1996
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0895-2026 Class III | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog…Labeling contains claims that are not consistently present. | Orthofix U.S. LLC | 11/03/2025Open, Classified |
| Z-0892-2026 Class III | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System…Labeling contains claims that are not consistently present. | Orthofix U.S. LLC | 11/03/2025Open, Classified |
| Z-1039-2026 Class II | Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to… | Medicrea International | 10/29/2025Open, Classified |
| Z-1038-2026 Class II | Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to… | Medicrea International | 10/29/2025Open, Classified |
| Z-0580-2026 Class II | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding…Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in… | Medtronic Sofamor Danek USA Inc | 09/16/2025Open, Classified |
| Z-2554-2025 Class II | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody SystemInserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty… | Seaspine Orthopedics Corporation | 08/06/2025Open, Classified |
| Z-2555-2025 Class II | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SPA 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of… | Orthofix U.S. LLC | 06/24/2025Open, Classified |
| Z-1432-2025 Class II | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile…The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant… | Orthofix U.S. LLC | 02/20/2025Open, Classified |
| Z-1065-2025 Class II | Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate…Complaints have been received regarding post-operative implant collapse. | Alphatec Spine, Inc. | 12/15/2024Open, Classified |
| Z-3163-2024 Class II | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System…Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. | Innovasis, Inc | 08/14/2024Open, Classified |
| Z-2461-2023 Class II | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-2457-2023 Class II | IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-2455-2023 Class II | IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-2453-2023 Class II | IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-2452-2023 Class II | IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-1698-2024 Class II | ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop…Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft… | Advanced Research Medical, LLC | 03/14/2023Completed |
| Z-0954-2023 Class II | CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208Specific lots of FLXfit implants have internal components that may have been manufactured using stainless… | CoreLink LLC | 10/20/2022Terminated |
| Z-1324-2022 Class II | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use…Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and… | DePuy Spine, Inc. | 05/20/2022Open, Classified |
| Z-1323-2022 Class II | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use…Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and… | DePuy Spine, Inc. | 05/20/2022Open, Classified |
| Z-1697-2021 Class II | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | K2M, Inc | 05/07/2021Terminated |
| Z-1696-2021 Class II | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | K2M, Inc | 05/07/2021Terminated |
| Z-1695-2021 Class II | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | K2M, Inc | 05/07/2021Terminated |
| Z-1440-2021 Class II | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree…The shelf box identifies a small device actually contains a large device, and the shelf box identifying a… | Medtronic Sofamor Danek USA, Inc | 03/17/2021Terminated |
| Z-1439-2021 Class II | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree…The shelf box identifies a small device actually contains a large device, and the shelf box identifying a… | Medtronic Sofamor Danek USA, Inc | 03/17/2021Terminated |
| Z-1437-2021 Class II | Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar.…Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found… | Stryker Spine | 03/11/2021Terminated |
| Z-2871-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2870-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2869-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2868-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2867-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2866-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2865-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2864-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2863-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2862-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2861-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2860-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2859-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2858-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2857-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2856-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2855-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2854-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2853-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2852-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2851-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-2850-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | Globus Medical, Inc. | 07/22/2020Terminated |
| Z-1156-2020 Class II | Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog:…Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the… | Medicrea International | 10/02/2019Terminated |
| Z-2504-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.Reports received of the device fracturing during insertion. | CTL Medical Corporation | 08/21/2019Completed |
| Z-2503-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.Reports received of the device fracturing during insertion. | CTL Medical Corporation | 08/21/2019Completed |