The Food and Drug Administration cleared more than 200 spine-related devices and technologies with 510(k) approval in 2023.
Note: FDA data is available through October. This article will be updated when November and December's information is available.
January
Cervical Spine Truss System from 4Web Medical
Galileo Vertebral Body Replacement Device from Bright Spine
Haymaker Screw System from OrthoCircle Spine
LumiVy Lumbar IBF System from Vy Spine
ZeSpine SI joint fusion system from Aegis Spine
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System from Aegis Spine
NuVasive Modulus-C Interbody System from NuVasive
NuVasive Reline System from NuVasive
PathLoc-TA Expandable Lumbar Cage System from L&K Biomed
CD Horizon Spinal System from Medtronic
SI-Cure Sacroiliac Joint Fusion System from Alevio
February
Stryker Q Guidance System with Cranial Guidance Software from Stryker
Tritanium C Anterior Cervical Cage from Stryker
Tritanium PL Cagefrom Stryker
Tritanium TL Curved Posterior Lumbar Cage from Stryker
Tritanium X PL Expandable Posterior Lumbar Cage from Stryker
Tritanium X TL Expandable Curved Posterior Lumbar Cage from Stryker
Stryker Spine VLIFTTM Vertebral Body Replacement System from Stryker
VLIFT-s Vertebral Body Replacement System from Stryker
Ascential IBD PEEKc Spacer from Stryker
AeroTM-AL Lumbar Cage System from Stryker
AeroTM-LL Lumbar Cage System from Stryker
Aero-C Cervical Cage System from Stryker
AVS Aria PEEK Spacer from Stryker
AVS Anchor-C Cervical Cage System from Stryker
AVS Anchor-L Spacer from Stryker
AVS TL PEEK Spacer from Stryker
AVS PL PEEK Spacer from Stryker
AVS AL PEEK Spacer from Stryker
AVS UniLIF PEEK Spacer from Stryker
AVS Navigator PEEK Spacer from Stryker
AVS AS PEEK Spacer from Stryker
MontereyTM AL Interbody System from Stryker
Aleutian IBF System from Stryker
Capri Corpectomy Cage System from Stryker
Cascadia Interbody System from Stryker
Chesapeake Stabilization System from Stryker
Mojave Expandable Interbody System from Stryker
Sahara Stabilization System from Stryker
Santorini Corpectomy Cage System from Stryker
Eminent Spine 3D Cervical Interbody Fusion System from Eminent Spine
Curiteva Porous PEEK Cervical Interbody Fusion System from Curiteva
Peridot-PT Anterior Cervical Intervertebral body fusion System from GBS Commonwealth
Manta Ray TDF Spacer from SeaSpine
MULTIPLE STRYKER DEVICES
Evolution Spine Interbody System from Evolution Spine
X-Pac Expandable LLIF Cage System from Expanding Innovations
Ti-Largo Cervical Interbody System from Flo Spine
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device from 4Web Medical
Pisces-SA STANDALONE ALIF Interbody System from Osseus Fusion Systems
PreView-III Anterior Cervical Plate System from Nexus Spine
VySpan PCT system from VySpine
G Surgical Marksman Spinal Deformity System from G Surgical
AccelFix Spinal Fixation System from L&K Biomed
March
Magnes-C Anterior Cervical Plate System from Fellowship of Orthopaedic Researchers
PathKeeper System from Pathkeeper Surgical
The Integrity Spine Core System from Integrity Spine
Remi Robotic Navigation System from Fusion Robotics
Calibrate LTX Interbody System from Alphatec Spine
CONDUIT Lateral Lumbar Intervertebral Fusion Cage from Medos International
Entasis 3D Dual-Lead Sacroiliac Implant System from CoreLink
Cervical Plate System from Double Medical Technology
ATEC Lateral Navigation Instruments from Alphatec
PEEK Spinal Infusion Cage from Changzhou Geasure Medical Apparatus
Huvex Interspinous Fusion System from Dio Medical
SPIRA-C Integrated Fixation System from Camber Spine
Athena III Cervical Plate System from Medyssey USA
Arthrex Knotless FiberTak Suture Anchor from Arthrex
Arthrex 3.9 mm SwiveLock Anchor from Athrex
Swedge Pedicle Screw Fixation System from Spinal Resources
April
ArtFX Spinal Fixation System from Art FX Medical
NEST-C Interbody System from Paonan Biotech
Kisar Stratford SI Screw System rom Anjali Investments
NITRO Interbody Fusion Cage System Family from CTL Medical
INTEGRATE -C Interbody Fusion System from Happe Spine
UniVy OsteoVy-Ti Cervical IBF System from Vy Spine
PYXIS 3D Titanium Cage System from GS Medical
HILINE Fixation System from Globus Medical
T-FIX 3DSI Joint Fusion System from Cutting Edge Spine
Altus Spine Monaco Pedicle Screw System from Altus Spine
Anatase Spine Surgery Navigation System from Remex Medical
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System from Kyocera Medical Technologies
May
Waypoint GPS from Waypoint Orthopedics
Advanced LumFix Spinal Fixation System from CG Bio
Ventana C Spinal System from Spinal Elements
ProLift Micro Expandable Spacer System from Life Spine
PressON Spinal Fixation System from Nexus Spine
Eminent Spine 3D Lumbar Interbody Fusion Systems from Eminent Spine
ClariVy Cervical IBF System from Vy Spine
ATEC Lateral Plate System from Alphatec
Kodiak Lumbar Spacer System from Met One Technologies
Syntheface PEEK Interference Screw from Suzhou Endophix
CoreLink Navigation Instruments from CoreLink
aprevo transforaminal lumbar interbody fusion device from Carlsmed
CD Horizon Spinal System from Medtronic
S-COMP Reform POCT Navigation Instruments from Precision Spine
June
XIA 4.5 Spinal System from Stryker Spine
XIA 4.5 Cortical Trajectory, from Stryker Spine
XIA 3 Spinal System, from Stryker Spine
Serrato Spinal System, from Stryker Spine
XIA Growth Rod Conversion Set, from Stryker Spine
XIA II Spinal System, from Stryker Spine
XIA Precision System, from Stryker Spine
XIA Anterior, from Stryker Spine
Diapason Spinal System, from Stryker Spine
Opus Spinal System, from Stryker Spine
Radius Spinal System, from Stryker Spine
Mantis Spinal System, from Stryker Spine
Mantis Redux, from Stryker Spine
Trio & Trio+ Spinal Fixation System, from Stryker Spine
ES2 Spinal System, from Stryker Spine
ES2 Augmentable Spinal System, from Stryker Spine
Oasys Occipito-Cervico-Thoracic System, from Stryker Spine
Nile Proximal Fixation Spinal System, from Stryker Spine
Nile Alternative Fixation Spinal System,from Stryker Spine
Escalate Laminoplasty System from Stryker Spine
Xenco Medical InterAlign Cervical Interbody System from Xenco Medical
F3D Interbody System from CoreLink
TiLink-L SI Joint Fusion System from Surgentec
Zavation ALIF System from Zavation Medical Products
EDEN Spinal Fixation MIS System from JMT Co.
VADER Pedicle System Navigated Instruments from Icotec
NuVasive Modulus ALIF System from NuVasive
Anatomic PEEK Cervical Fusion System with Nanotechnology from Nanovis
CODA Anterior Cervical Plate System from Pioneer SUrgical Technology
Zevo Anterior Cervical Plate System from Medtronic Sofamor Danek USA
Axis Anterior Cervical Plate System from Southern Medical
Solar Lumbar Interbody Fusion System from DeGen Medical
Curiteva Laminoplasty System from Curiteva
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System from L&K Biomed
iFuse TORQ Implant System from Si-Bone
July
Edge Upper Cervical System from Spinal Simplicity
Integral Titanium Cervical Interbody from Nvision Biomedical Technologies
CarboClear Cervical Cage System from Carbofix Orthopedics
CarboClear Cervical VBR System from Carbofix Orthopedics
NextAR Spine Platform from Medacta
Zavation Navigation Instrument System from Zavation Medical Products
SPIRA Posterior Lumbar Spacers from Camber Spine
NanoHive Medical Lumbar Interbody System from NanoHive Medical
CarboClear X Pedicle Screw System from Carbofix Orthopedics;
CarboClear X Navigated Instruments from Carbofix Orthopedics
CarboClear X Fenestrated Pedicle Screw System with High V+ Bone Cement from Carbofix Orthopedics
Calibrate PSX Interbody System from Alphatec
Calibrate NanoTec PSX Interbody System from Alphatec
FORTIS and HANA Anterior Cervical Plate System from K&J Consulting Corp.
Rex Anterior Cervical Plate System from K&J Consulting Corp.
BALTEUM & BALTEUM-ONE Lumbar Plate System from K&J Consulting Corp.
Osprey Anterior Cervical Plate System from K&J Consulting Corp.
MySpine Unilateral Guides from Medacta
Spine CAMP (1.1) from Medical Metrics
NuVasive CoRoent Small Interbody System from NuVasive
NuVasive CoRoent Small Contoured Interbody System from NuVasive
NuVasive CoRoent Small Interlock System from NuVasive
NuVasive CoRoent Small Interlock II System from NuVasive
NuVasive CoRoent Small Ti-C System from NuVasive
NuVasive Cohere Cervical Interbody System from NuVasive
CastleLoc-P Anterior Cervical Plate System from L&K Biomed
AccelFix Lumbar Plate System from L&K Biomed
CastleLoc-S Posterior Cervical Fixation System from L&K Biomed
PathLoc SI Joint Fusion System from L&K Biomed
ProMIS Fixation System from Premia Spine
Adena-Zina Spinal System from Shanghai Sanyou Medical
SI-Cure Sacroiliac Joint Fusion System from Alevio
August
Titus Titanium Cervical from Sagico
Lumbar Expandable lnterbody Spacers from Globus Medical
Spine Planning (2.0), Elements Spine Planning from Brainlab
SPICCA Cervical Fusion Cages from Southern Medical
SPICCA Stand-Alone Cervical Fusion Cages from Southern Medical
LineSider Spinal System from Integrity Implants
Sapphire X3 Anterior Cervical Plate System from Spinal Elements
HOLO Portal Surgical Guidance System from Surgalign
Stable-C Interbody System from Nexus Spine
primaLOK SP Interspinous Fusion System from Wenzel Spine
Zavation Connector System from Zavation Medical
Xenix Medical Sacroiliac Fixation System from Xenix Medical
TiLink-L Joint Fusion System from SurGenTec
CATAMARAN SI Joint Fusion System from Tenon Medical
CoreLink Navigation Instruments from CoreLink
ZSFab Cervical Interbody System from ZSFab
Zenius Spinal System from Medyssey
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System from L&K Biomed
September
neoWave LS Lumbar Straight from Xenix Medical
neoWave C Cervical from Xenix Medical
Ti3D Cervical from Xenix Medical
Integrity-SI Fusion System from OsteoCentric Technologies
TiLink-P SI Joint Fusion System from SurGenTec
NIDO Pedicle Screw System from Kalitec Medical
VariLift-C Interbody Fusion System from Wenzel Spine
OnPoint Augmented Reality Spine System from OnPoint Surgical
TriALTIS Spine System from Medos International
Cervical Spine Truss System from 4Web Medical
Skyway Anterior Cervical Plate System from Kyocera Medical
Invictus Spinal Fixation System from Alphatec
Fusion Robotic Navigation System from Alphatec
Stable-L Standalone Lumbar Interbody System from Nexus Spine
Stable-C Interbody System from Nexus Spine
KHEIRON Spinal Fixation System, including patient specific K-ROD from SMAIO
October
Vital Spinal Fixation System from ZimVie Spine.
Acro Composites Interbody System from Acro Composites.
Zeus Spinal System from Shanghai Sanyou Medical Co.
Pearla TL Posterior Thoracolumbar Fixation System from Spineart.
Stable-L Standalone Lumbar Interbody System from Nexus Spine.
Veos Spinal Fixation System from Spineway.
Pro-Link & Pro-Link Ti Barbs Cervical Spacer System from Life Spine.
Anax 5.5 Spinal System from Innosys.
VyLink Spinal Screw System from Vy Spine.
OptiMesh Multiplanar Expandable Interbody Fusion System from Spineology.
Momentum Posterior Spinal Fixation System with G21 V-Steady Bone Cement from Ulrich 16. Medical USA.
ClariVy Cervical IBF System from Vy Spine.
SpineEOS from EOS imaging.
MedactaLIF Anterior Lag Extension from Medacta International.
Ascend VBR System, Ascend NanoTec VBR System from Alphatec Spine.
Reunion Sacroiliac Joint Fusion System from Astura Medical.
Victory Lumbar Plate System from Globus Medical.
CarboClear Pedicle Screw System from Carbofix Orthopedics.
Rigel 3DR Standalone Anterior Cervical Interbody Fusion System from MiRus.
Vy Spine VyLam Laminoplasty System from Vy Spine.
Rigel 3DR Anterior Cervical Corpectomy System from MiRus.
KeyLift Expandable Interlaminar Stabilization System from FloSpine.
Calibrate CCX Interbody System from Alphatec Spine.
Ripley Spinal Screw System by Sagico from Sagico.
Rexious Spinal Fixation System, Statera Spinal System, from K&J Consulting Corp.
Peridot-TD Spacer System from GBS Commonwealth.
PressON Spinal Fixation System from Nexus Spine.
Solace Sacroiliac Fixation System from Xenix Medical.