Intervertebral Fusion Device With Integrated Fixation, Lumbar
FDA product code OVD · Class II (moderate risk) · 21 CFR 888.3080 · Orthopedic
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
205510(k) clearances
0PMA approvals
36recalls
Implantimplanted device
Manufacturers
- Globus Medical, Inc. 11
- Nu Vasive, Incorporated 10
- K2m, Inc. 7
- Medacta International S.A. 5
- Alphatec Spine, Inc. 5
- Renovis Surgical Technologies, LLC 5
- Life Spine, Inc. 4
- Spineart 4
- Titan Spine, LLC 4
- Ldr Spine USA 4
- Clariance, Sas 4
- Spineology, Inc. 4
- Nuvasive, Inc. 4
- Kyocera Medical Technologies, Inc. 4
- Nexus Spine, LLC 4
- Centinel Spine, Inc. 4
- Carlsmed, Inc. 4
- Biomet Spine 4
- Innovasis, Inc. 4
- Stryker Corporation 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional | Avalign Technologies, Inc. | 07/10/2025SE |
| K251644 | ProAM ALIF SystemOVD · Special | Pro Surgical, Inc. | 06/24/2025SE |
| K250845 | Curiteva Porous PEEK Standalone ALIF SystemOVD · Traditional | Curiteva, Inc. | 06/18/2025SE |
| K251459 | OneLIF Interbody Fusion SystemOVD · Special | Novapproach Spine, LLC | 06/12/2025SE |
| K243934 | Stable-L Lumbar Interbody SystemOVD · Traditional | Nexus Spine, LLC | 04/30/2025SE |
| K243386 | Ventris Intervertebral Body Fusion DeviceOVD · Traditional | Acuity Surgical Devices, LLC | 04/22/2025SE |
| K250603 | AxTiHA® Stand-Alone ALIF SystemOVD · Special | Innovasis | 03/24/2025SE |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…OVD · Traditional | Carlsmed, Inc. | 03/17/2025SE |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Special | Carlsmed, Inc. | 12/13/2024SE |
| K243191 | Atlas Spine Lateral Expandable Interbody SystemOVD · Traditional | Atlas Spine, Inc. | 11/26/2024SE |
| K241077 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 10/29/2024SE |
| K241992 | Catalyft LS Expandable Interbody SystemOVD · Traditional | Medtronic Sofamor Danek USA, Inc. | 10/28/2024SE |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Traditional | Carlsmed, Inc. | 10/09/2024SE |
| K241487 | Interwedge® Standalone LateralOVD · Traditional | Foundation Surgical Group, Inc. | 10/02/2024SE |
| K241321 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | Spineart SA | 07/18/2024SE |
| K240368 | E3D-A Interbody SystemOVD · Traditional | Evolution Spine | 05/15/2024SE |
| K240126 | ProAM ALIF SystemOVD · Traditional | Pro Surgical, Inc. | 05/03/2024SE |
| K240623 | Omnia Medical TiBrid-SA SystemOVD · Traditional | Omnia Medical, LLC | 04/24/2024SE |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD · Traditional | 4Web Medical, Inc. | 04/22/2024SE |
| K232432 | E3D-A Interbody SystemOVD · Traditional | Evolution Spine | 01/30/2024SE |
| K232123 | MectaLIF Anterior Lag ExtensionOVD · Traditional | Medacta International S.A. | 10/18/2023SE |
| K231486 | Stable-L Standalone Lumbar Interbody SystemOVD · Traditional | Nexus Spine, LLC | 10/12/2023SE |
| K232097 | IdentiTi ALIF Interbody SystemsOVD · Traditional | Alphatec Spine, Inc. | 09/25/2023SE |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVD · Special | Nexus Spine, LLC | 09/18/2023SE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD · Traditional | MiRus, LLC | 09/11/2023SE |
| K230894 | NuVasive Modulus ALIF SystemOVD · Traditional | Nu Vasive, Incorporated | 06/16/2023SE |
| K230731 | Zavation ALIF SystemOVD · Traditional | Zavation Medical Products, LLC | 06/14/2023SE |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Special | Kyocera Medical Technologies, Inc. | 04/21/2023SE |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional | Camber Spine Technologies | 03/30/2023SE |
| K223413 | Pisces-SA STANDALONE ALIF Interbody SystemOVD · Traditional | Osseus Fusion Systems | 02/10/2023SE |
| K223146 | EVOLUTION SPINE Interbody SystemOVD · Traditional | Evolution Spine | 02/07/2023SE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody FusionOVD · Traditional | Astura Medical | 01/19/2023SE |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Traditional | Carlsmed, Inc. | 11/22/2022SE |
| K221545 | MectaLIF Anterior ExtensionOVD · Traditional | Medacta International S.A. | 10/24/2022SE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional | Nu Vasive, Incorporated | 10/21/2022SE |
| K221936 | Standalone ALIF Interbody Fusion SystemOVD · Traditional | Eminent Spine | 10/17/2022SE |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA)OVD · Traditional | Southern Medical (Pty) , Ltd. | 10/14/2022SE |
| K222561 | AlignOVD · Special | Acuity Surgical Devices, LLC | 09/23/2022SE |
| K220610 | Solo-LOVD · Traditional | Aurora Spine, Inc. | 05/27/2022SE |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD · Traditional | MiRus, LLC | 05/13/2022SE |
| K213935 | PISCES-SA Standalone ALIF Interbody SystemOVD · Traditional | Osseus Fusion Systems | 05/06/2022SE |
| K211837 | Altus Spine Interbody Standalone Fusion SystemOVD · Traditional | Altus Partners, LLC | 04/19/2022SE |
| K213118 | Dakota ALIF SystemOVD · Traditional | Precision Spine, Inc. | 04/01/2022SE |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion SystemOVD · Traditional | Astura Medical | 03/30/2022SE |
| K212498 | Stable-L Standalone Lumbar Interbody SystemOVD · Traditional | Nexus Spine, LLC | 03/18/2022SE |
| K212980 | Tesera-k ALIF SystemOVD · Traditional | Kyocera Medical Technologies, Inc. | 01/07/2022SE |
| K212967 | AxTiHA Stand-Alone ALIF SystemOVD · Special | Innovasis, Inc. | 10/15/2021SE |
| K210590 | Axis Spine Technologies ALIFOVD · Traditional | Axis Spine Technologies, Ltd. | 09/29/2021SE |
| K211769 | OneLIF Intervertebral Body Replacement SystemOVD · Traditional | Novapproach Spine | 09/07/2021SE |
| K201671 | A-Link ZOVD · Traditional | Acuity Surgical Devices, LLC | 05/04/2021SE |
| K203742 | IdentiTi ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine, Inc. | 04/09/2021SE |
| K202032 | Idys LLIF 3DTiOVD · Traditional | Clariance, Sas | 04/01/2021SE |
| K210271 | NuVasive Modulus ALIF SystemOVD · Special | Nu Vasive, Incorporated | 03/01/2021SE |
| K203207 | Omnia Medical TiBrid-SAOVD · Traditional | Omnia Medical, LLC | 12/23/2020SE |
| K202230 | NEXXT MATRIXX Stand Alone ALIF SystemOVD · Traditional | Nexxt Spine, LLC | 12/15/2020SE |
| K202190 | Oculus-SA Lumbar Cage SystemOVD · Traditional | Neurostructures | 10/02/2020SE |
| K201585 | Monterey AL Interbody SystemOVD · Traditional | Stryker Corporation | 08/10/2020SE |
| K201087 | CORBEL SpacersOVD · Traditional | Globus Medical, Inc. | 07/31/2020SE |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion DeviceOVD · Traditional | 4Web, Inc. | 05/29/2020SE |
| K200352 | Axis Spine Technologies ALIFOVD · Traditional | Axis Spine Technologies, Ltd. | 05/20/2020SE |
| K200541 | Hive Stand-alone Anterior Lumbar Interbody SystemOVD · Traditional | Hd Lifesciences, LLC | 04/28/2020SE |
| K192492 | EL CAPITAN Anterior Lumber Interbody SystemOVD · Traditional | Astura Medical, LLC | 04/21/2020SE |
| K200338 | ProLift Lateral FixatedOVD · Traditional | Life Spine, Inc. | 04/17/2020SE |
| K193593 | NuVasive 3DP Interfixated ALIF SystemOVD · Traditional | Nu Vasive, Incorporated | 03/25/2020SE |
| K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Traditional | Kyocera Medical Technologies, Inc. | 02/04/2020SE |
| K192993 | Scarlet Al-TOVD · Traditional | Spineart | 01/22/2020SE |
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…OVD · Traditional | Titan Spine, Inc. | 01/08/2020SE |
| K191834 | Stand-Alone ALIF Titanium SystemOVD · Traditional | Life Spine, Inc. | 12/16/2019SE |
| K192168 | Idys ALIF ZP 3DTiOVD · Traditional | Clariance, Sas | 11/04/2019SE |
| K190179 | SAHARA Stabilization SystemOVD · Traditional | K2m, Inc. | 10/03/2019SE |
| K192054 | Endoskeleton TAS PlateOVD · Special | Titan Spine, Inc. | 08/29/2019SE |
| K192047 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | Spineology, Inc. | 08/23/2019SE |
| K182139 | AXTi Titanium Stand-Alone ALIF SystemOVD · Traditional | Innovasis, Inc. | 06/21/2019SE |
| K191263 | Idys ALIF TiVacOVD · Special | Clariance, Sas | 06/06/2019SE |
| K190877 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | Spineart | 05/29/2019SE |
| K191091 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | Spineology, Inc. | 05/23/2019SE |
| K183426 | MectaLIF Anterior Stand Alone ExtensionOVD · Traditional | Medacta International S.A. | 03/15/2019SE |
| K181096 | Avenue P Cage SystemOVD · Traditional | Zimmer Biomet Spine, Inc. | 01/15/2019SE |
| K181118 | Reliance Lumbar IBF SystemOVD · Traditional | Reliance Medical Systems | 01/09/2019SE |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemOVD · Traditional | Renovis Surgical Technologies | 12/07/2018SE |
| K182195 | Arco-SA Lumbar Cage SystemOVD · Special | Neurostructures, Inc. | 11/09/2018SE |
| K181818 | Scarlet AL-TOVD · Traditional | Spineart | 10/09/2018SE |
| K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemOVD · Traditional | Life Spine, Inc. | 09/13/2018SE |
| K181386 | NuVasive Brigade Lateral SystemOVD · Traditional | Nu Vasive, Incorporated | 08/24/2018SE |
| K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar SystemOVD · Traditional | Corelink, LLC | 08/10/2018SE |
| K180695 | FBC 921 (Alif)OVD · Traditional | Fbc Device Aps | 07/12/2018SE |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Traditional | Renovis Surgical Technologies, Inc. | 06/14/2018SE |
| K180519 | HARRIER-SA Lumbar Interbody SystemOVD · Traditional | Choicespine, LP | 05/16/2018SE |
| K180002 | Rampart One Lumbar Interbody Fusion DeviceOVD · Traditional | Spineology, Inc. | 04/25/2018SE |
| K173432 | ENZA-A Titanium ALIFOVD · Traditional | Camber Spine Technologies | 04/18/2018SE |
| K173606 | SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…OVD · Traditional | SeaSpine Orthopedics Corporation | 04/13/2018SE |
| K173082 | Arco-SA Lumbar Cage SystemOVD · Traditional | Neurostructures, Inc. | 03/29/2018SE |
| K172941 | CASCADIA Interbody SystemOVD · Traditional | K2m | 02/12/2018SE |
| K172019 | Brisbane ALIF Device, Gladstone ALIF DeviceOVD · Traditional | Signature Orthopaedics Pty, Ltd. | 11/29/2017SE |
| K172083 | Idys ALIF SystemOVD · Traditional | Clariance, Sas | 11/08/2017SE |
| K172328 | SOVEREIGN Spinal SystemOVD · Traditional | Medtronic Sofamor Danek USA, Inc. | 11/02/2017SE |
| K170157 | INDEPENDENCE® SpacersOVD · Traditional | Globus Medical, Inc. | 09/25/2017SE |
| K170855 | T-Rex Standalone ALIFOVD · Traditional | Siats, LLC | 09/07/2017SE |
| K171567 | IRIX-A Lumbar Integrated Fusion SystemOVD · Traditional | X-Spine Systems, Inc. | 08/28/2017SE |
| K163670 | Rampart One Lumbar Interbody Fusion DeviceOVD · Traditional | Spineology, Inc. | 05/08/2017SE |
| K170592 | NuVasive BASE Interfixated Titanium SystemOVD · Traditional | Nu Vasive, Incorporated | 04/26/2017SE |
| K162236 | Ax Stand-Alone ALIF SystemOVD · Traditional | Innovasis, Inc. | 04/20/2017SE |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic…OVD · Traditional | Titan Spine, LLC | 04/13/2017SE |
| K170455 | MectaLIF Anterior Stand AloneOVD · Special | Medacta International S.A. | 03/16/2017SE |
| K163543 | Biomet Fusion SystemOVD · Special | Zimmer Biomet Spine, Inc. | 02/28/2017SE |
| K162680 | SOVEREIGN® Spinal SystemOVD · Traditional | Medtronic Sofamor Danek USA, Inc. | 12/14/2016SE |
| K162351 | SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceOVD · Traditional | SeaSpine Orthopedics Corporation | 12/01/2016SE |
| K161993 | Leva® Anterior Interbody SystemOVD · Traditional | Spine Wave, Inc. | 11/22/2016SE |
| K161379 | ELSA SpacersOVD · Traditional | Globus Medical, Inc. | 09/29/2016SE |
| K161173 | Avenue® T TLIF CageOVD · Traditional | Ldr Spine USA, Inc. | 09/28/2016SE |
| K161129 | Pillar SA PTCOVD · Traditional | Orthofix, Inc. | 09/08/2016SE |
| K160597 | INDEPENDENCE MIS SpacersOVD · Traditional | Globus Medical, Inc. | 08/29/2016SE |
| K160605 | MectaLIF Anterior Stand-AloneOVD · Traditional | Medacta International | 07/21/2016SE |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-SpacersOVD · Traditional | Globus Medical, Inc. | 07/15/2016SE |
| K153720 | ENZA Zero-Profile Anterior Interbody FusionOVD · Traditional | Camber Spine Technologies | 05/03/2016SE |
| K160051 | NuVasive® Interfixated Interbody SystemOVD · Traditional | Nu Vasive, Incorporated | 04/20/2016SE |
| K160291 | Optimus ALIF SystemOVD · Special | Amendia, Inc. | 02/18/2016SE |
| K151312 | VerteLP Interbody Fusion DeviceOVD · Traditional | Vgi, LLC | 01/13/2016SE |
| K151481 | Sahara Stabilization SystemOVD · Traditional | K2m, Inc. | 12/21/2015SE |
| K152943 | NuVasive Foundation-LL SystemOVD · Traditional | Nu Vasive, Incorporated | 12/01/2015SE |
| K150673 | SYNFIX Evolution Secured Spacer SystemOVD · Traditional | Synthes (USA) Products, LLC | 08/21/2015SE |
| K151214 | ALIF Interfixated SystemOVD · Traditional | Nu Vasive, Incorporated | 06/25/2015SE |
| K142645 | Avenue T TLIF CageOVD · Traditional | Ldr Spine USA, Inc. | 06/11/2015SE |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD · Traditional | Centinel Spine, Inc. | 06/08/2015SE |
| K142487 | Chesapeake Stabilization SystemOVD · Traditional | K2m, Inc. | 05/07/2015SE |
| K143228 | Ancora LLC Interbody Fusion DeviceOVD · Traditional | Frontier Medical Devices, Inc. | 02/26/2015SE |
| K142498 | MAGNIFY and MAGNIFY-S SpacersOVD · Traditional | Globus Medical, Inc. | 02/26/2015SE |
| K141798 | Sypher Spacer SystemOVD · Traditional | Biogennix, LLC | 02/19/2015SE |
| K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…OVD · Traditional | Stryker Corporation | 01/26/2015SE |
| K141187 | Impix Alif S/AOVD · Traditional | Medicrea International SA | 01/15/2015SE |
| K142271 | Zavation Z-Link LumbarOVD · Traditional | Zavation, LLC | 12/19/2014SE |
| K133827 | A-Link ZOVD · Traditional | Osteo Vasive, LLC | 11/17/2014SE |
| K142066 | Aero-Ll Lumbar Cage SystemOVD · Traditional | Stryker Corporation | 11/13/2014SE |
| K141942 | Midline II TiOVD · Traditional | Centinel Spine, Inc. | 11/07/2014SE |
| K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemOVD · Special | Renovis Surgical Technologies, Inc. | 10/15/2014SE |
| K141791 | Biomet Fusion SystemOVD · Traditional | Biomet Spine | 10/09/2014SE |
| K133947 | Irix-A Lumbar Integrated Fusion SystemOVD · Traditional | X-Spine Systems, Inc. | 07/29/2014SE |
| K140479 | Coroent Xl-F SystemOVD · Traditional | Nu Vasive, Incorporated | 07/28/2014SE |
| K133494 | Chesapeake Spinal SystemOVD · Traditional | K2m, Inc. | 06/10/2014SE |
| K133328 | Aero-Al Lumbar Cage SystemOVD · Traditional | Stryker Corporation | 05/30/2014SE |
| K132596 | Proposed OptimusOVD · Traditional | Custom Spine, Inc. | 04/11/2014SE |
| K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) SystemOVD · Special | Renovis Surgical Technologies, Inc. | 03/27/2014SE |
| K133286 | Midline (TM)OVD · Special | Centinel Spine, Inc. | 01/09/2014SE |
| K131276 | Lateral SynfixOVD · Traditional | Synthes (USA) Products, LLC | 01/06/2014SE |
| K132559 | Monument SpacersOVD · Traditional | Globus Medical, Inc. | 12/30/2013SE |
| K131723 | Coroent Single Tab SystemOVD · Traditional | Nuvasive, Inc. | 09/20/2013SE |
| K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) SystemOVD · Abbreviated | Renovis Surgical Technologies, LLC | 09/18/2013SE |
| K130641 | Logic Stand-Alone Intervertebral Body Fusion DeviceOVD · Traditional | Binder Biomedical, Inc. | 09/13/2013SE |
| K130461 | Stalif XOVD · Traditional | Centinel Spine, Inc. | 08/28/2013SE |
| K131547 | Lanx Fusion SystemOVD · Special | Lanx, Inc. | 07/12/2013SE |
| K124034 | Mectalif AnteriorOVD · Traditional | Medacta International | 05/17/2013SE |
| K130445 | Vault Alif SystemOVD · Special | Spinal USA | 04/25/2013SE |
| K123045 | Brigade Standalone SystemOVD · Special | Nuvasive, Inc. | 04/16/2013SE |
| K123767 | Lanx Fusion System- SAOVD · Traditional | Lanx, Inc. | 03/18/2013SE |
| K123993 | Solus Anterior Lumbar Interbody Fusion (Alif) SystemOVD · Traditional | Alphatec Spine, Inc. | 03/05/2013SE |
| K112700 | Frontier Sadl Interbody Fusion DeviceOVD · Traditional | Frontier Medical Devices, Inc. | 11/01/2012SE |
| K120869 | Anchor-L Lumbar CageOVD · Traditional | Stryker Spine | 10/25/2012SE |
| K122168 | Visualif Challenging Access PlateOVD · Special | Spine Smith Partners L.P. | 10/11/2012SE |
| K121982 | Sovereign Spinal SystemOVD · Special | Medtronic Sofamor Danek | 07/26/2012SE |
| K113285 | LDR Spine USA Avenue L Interbody FusionOVD · Traditional | Ldr Spine USA, Inc. | 07/26/2012SE |
| K121211 | Vu Apod Intervertebral Body Fusion DeviceOVD · Special | Theken Spine, LLC | 06/27/2012SE |
| K120101 | Independence SpacerOVD · Special | Globus Medical, Inc. | 03/27/2012SE |
| K120557 | Solitarie PEEK Anterior Spinal System-To Be Called Colitaire 35OVD · Special | Biomet Spine & Bone Healing Technologies | 03/19/2012SE |
| K120031 | Chesapeake Spinal SystemOVD · Special | K2m, Inc. | 03/16/2012SE |
| K112561 | Nuvasive Coroent No-Profile SystemOVD · Special | Nuvasive, Inc. | 03/13/2012SE |
| K110063 | Sovereign Spinal SystemOVD · Traditional | Medtronic Sofamor Danek, Inc. | 10/04/2011SE |
| K110327 | LDR Spine Roi-A Interbody Fusion SystemOVD · Special | Ldr Spine USA | 09/30/2011SE |
| K111626 | Endoskeleton(R) TasOVD · Traditional | Titan Spine, LLC | 09/09/2011SE |
| K111122 | Aesculap Sibd XP Spinal SystemOVD · Traditional | Aesculap Implant Systems, Inc. | 08/04/2011SE |
| K103382 | Intercontinental Plate-SpacerOVD · Traditional | Globus Medical, Inc. | 05/20/2011SE |
| K103369 | Vault Alif SystemOVD · Traditional | Spinal USA | 04/04/2011SE |
| K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemOVD · Traditional | Alphatec Spine, Inc. | 03/30/2011SE |
| K102738 | Lanx Fusion SystemOVD · Traditional | Lanx, LLC | 02/10/2011SE |
| K102121 | Eclipse Vertebral Spacer System-LumbarOVD · Traditional | Apollo Spine, Inc. | 01/12/2011SE |
| K100516 | Anyplus PEEK CagesOVD · Traditional | GS Medical Co., Ltd. | 12/03/2010SE |
| K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemOVD · Special | Spine Smith Partners L.P. | 09/30/2010SE |
| K101310 | Vu Apod Intervertebral Body Fusion DeviceOVD · Traditional | Theken Spine, LLC | 09/02/2010SE |
| K100802 | Aesculap Implant Systems Sibd Spinal SystemOVD · Traditional | Aesculap Implant Systems, Inc. | 07/20/2010SE |
| K100043 | Coroent XLR Standalone SystemOVD · Traditional | Nuvasive, Inc. | 06/16/2010SE |
| K093808 | Incite Innovation Stand Alone Interbody Fusion DeviceOVD · Traditional | Incite Innovation, LLC | 03/24/2010SE |
| K093629 | Solitaire and Solitaire PEEK Anterior Spinal SystemOVD · Traditional | Biomet Spine | 03/09/2010SE |
| K092211 | Chesapeake Spinal SystemOVD · Traditional | K2m, Inc. | 03/05/2010SE |
| K091301 | Life Spine Stand-Alone Spacer SystemOVD · Traditional | Life Spine | 12/15/2009SE |
| K091813 | Intrepid Spinal SystemOVD · Traditional | Medtronic Sofamor Danek | 11/17/2009SE |
| K083475 | Lucent MagnumOVD · Traditional | Spinal Elements, Inc. | 02/13/2009SE |
| K082926 | Zuma, Model 55-XXXX/56-XXXXOVD · Traditional | Seaspine, Inc. | 12/22/2008SE |
| K082252 | Independence SpacerOVD · Traditional | Globus Medical, Inc. | 11/05/2008SE |
| K081711 | Lucent Magnum+OVD · Traditional | Spinal Elements, Inc. | 09/11/2008SE |
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceOVD · Special | Blackstone Medical, Inc. | 08/28/2008SE |
| K081501 | Solitaire Anterior Spinal SystemOVD · Traditional | Biomet Spine | 07/02/2008SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2213-2026 Class II | OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm…Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may… | Novapproach Spine, LLC | 04/23/2026Open, Classified |
| Z-0893-2026 Class III | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System…Labeling contains claims that are not consistently present. | Orthofix U.S. LLC | 11/03/2025Open, Classified |
| Z-1491-2025 Class II | Monterey AL Implant Inserter; 22mm; Catalog 48019140.Potential for the gold unlock button to separate from the inserter. | Stryker Spine | 02/28/2025Open, Classified |
| Z-1490-2025 Class II | Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.Potential for the gold unlock button to separate from the inserter. | Stryker Spine | 02/28/2025Open, Classified |
| Z-1489-2025 Class II | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.Potential for the gold unlock button to separate from the inserter. | Stryker Spine | 02/28/2025Open, Classified |
| Z-1488-2025 Class II | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.Potential for the gold unlock button to separate from the inserter. | Stryker Spine | 02/28/2025Open, Classified |
| Z-1177-2025 Class II | Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X…Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect… | XTANT Medical Holdings, Inc | 01/03/2025Open, Classified |
| Z-2557-2025 Class II | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers…Failure of fusion system instruments in the field. | Omnia Medical | 07/15/2024Open, Classified |
| Z-2556-2025 Class II | TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30…Failure of fusion system instruments in the field. | Omnia Medical | 07/15/2024Open, Classified |
| Z-1182-2024 Class II | IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 /…Due to reports of intraoperative graft bolt implantation breakages. | Alphatec Spine, Inc. | 01/26/2024Open, Classified |
| Z-2454-2023 Class II | IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarThere 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-2123-2023 Class II | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-2122-2023 Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-2121-2023 Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-2120-2023 Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-2119-2023 Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-2118-2023 Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-2117-2023 Class II | Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF…There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic… | Medtronic Sofamor Danek USA Inc | 06/06/2023Open, Classified |
| Z-1426-2023 Class II | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S…JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble… | Spineart SA | 03/16/2023Open, Classified |
| Z-1405-2023 Class II | MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | Medacta Usa Inc | 03/08/2023Completed |
| Z-1404-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | Medacta Usa Inc | 03/08/2023Completed |
| Z-1403-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | Medacta Usa Inc | 03/08/2023Completed |
| Z-1402-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | Medacta Usa Inc | 03/08/2023Completed |
| Z-1401-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | Medacta Usa Inc | 03/08/2023Completed |
| Z-1400-2023 Class II | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion deviceThere is a potential for breakage of the small screw used to affix the anti-backout plate. | Medacta Usa Inc | 03/08/2023Completed |
| Z-0246-2023 Class II | OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a…The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. | Novapproach Spine LLC | 10/12/2022Terminated |
| Z-0085-2022 Class II | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12…Engraving on implants may not match what is listed on the pouch labels. | Medtronic Sofamor Danek USA Inc | 09/02/2021Terminated |
| Z-2355-2020 Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open…Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the… | Acuity Surgical Devices, LLC | 01/07/2019Open, Classified |
| Z-2354-2020 Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary…Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the… | Acuity Surgical Devices, LLC | 01/07/2019Open, Classified |
| Z-2100-2018 Class II | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kitIFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated | VGI Medical, LLC | 04/09/2018Terminated |
| Z-0891-2017 Class II | Optimus Fixed AwlComplaints that the tip of the awl broke after impaction during surgery. | Amendia, Inc | 11/22/2016Terminated |
| Z-1253-2016 Class II | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number…Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled… | Biomet Spine, LLC | 02/12/2016Terminated |
| Z-0400-2014 Class II | LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver -…Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because… | Lanx, Inc. | 11/04/2013Terminated |
| Z-0983-2015 Class II | Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline…The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the… | Biomet Spine, LLC | 08/22/2013Terminated |
| Z-0982-2015 Class II | Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.…The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting… | Biomet Spine, LLC | 08/22/2013Terminated |
| Z-0978-2015 Class II | Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No.…The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the… | Biomet Spine, LLC | 08/22/2013Terminated |