Since the beginning of the year, 158 spine-related devices have been granted FDA 510(k) clearance:
January
Nex-D2 Posterior Fixation System from OrthoSurgical
Genesys Spine 3DP Cervical Interbody System from Genesys Spine
Endoskeleton TL Interbody Fusion Device from Titan Spine
Symphony OCT System from Medos International
Evol ha – D Lateral Interbody Fusion System from Cutting Edge Spine
Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek
TrellOss-L MPF from Nexxt Spine
Streamline TL Spinal Fixation System from Pioneer Surgical Technology
CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek
ProLift Expandable System from Life Spine
CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva
SureMAX Family of Cervical Spacers from Additive Implants
M.U.S.T. Pedicle Screw System from Medacta International
Nexxt Matrixx System from Nexxt Spine
CorticaLINK Spinal Fusion Platform from Spine Smith Holdings
February
Atlas Spine Expandable Cervical Standalone Interbody System from Atlas Spine
Yukon OCT Spinal System from Stryker
Mojave Expandable Interbody System from Stryker
Daytona Small Stature Growth Rod Conversion Set from SeaSpine Orthopedics
Largo PEEK Interbody System from FloSpine
KMTI Teresa SA Anterior Lumbar Interbody Fusion System from Kyocera
Perla TL Posterior Osteosynthesis System from Spineart
Nexxt Matrixx System from Nexxt Spine
OrthoCircle Spine Pedicle Screw System from OrthoCircle Spine
NuVasive X-Core Expandable VBR System from NuVasive
Steerable Plateau Ti from Life Spine
SpineNet SSP System from SpineNet
Daytona Small Stature Spinal System from SeaSpine Orthopedics
March
Megafix Pedicle Screw Spinal System from SeohanCare
Capstone Spinal System, Clydesdale PTC Spinal System, Crescent Spinal System from Medtronic Sofamor Danek
Icotec Cervical Cage from icotec
Mecta-C Stand Alone from Medacta
Response Spine System from OrthoPediatrics
Nano FortiFix System from Nanovis Spine
CarboClear Lumbar Cage System from CarboFix Orthopedics
SeaSpine Skipjack System from SeaSpine Orthopedics
Tritium Sternal Cable Plate System from Pioneer Surgical Technology
SI-Bone iFuse Implant System from SI-Bone
NuVasive Cohere Thoracolumbar Interbody System from NuVasive
NuVasive 3DP Interfixated ALIF System from NuVasive
NorthStar OCT Spinal System from SeaSpine Orthopedics
MectaLIF Anterior Simple from Medacta International
Response BandLoc Spinal Fixation from OrthoPediatrics
Sea-Link Anterior Cervical Plate System from Indius Medical Technologies
Lospa IS Spinal Fixation System from Corentec
The Gecko Spinal System from Ortho Development Corporation
Nexxt Matrixx Stand Alone Cervical-Turn Lock System from Nexxt Spine
April
Comet Lumbar Interbody Fusion Cage from Baui Biotech
Sirion Lateral Lumber Interbody System from Astura Medical
Verticale Cervical System from Silony Medical
Galileo Vertebral Body Replacement Device from Bright Spine
El Captain Anterior Lumber Interbody System from Astura Medical
Symphony OCT System from Medos International
Spira-C Integrated Fixation System from Camber Spine Technologies
Origin Anterior Cervical Plate System from Orthopaedic & Spine Development
SeaSpine Reef TH System from SeaSpine Orthopedics
ARx Spinal System from Life Spine
ProLift Lateral Fixated from Life Spine
Biolign Roto-Loc Cervical Plate System from Elite Surgical Supplies
Hive Stand-alone Anterior Lumbar Interbody System from HD LifeSciences
Evos Lumbar Interbody System from Cutting Edge Spine
Tritanium X TL Expandable Curve Posterior Lumbar Cage from Stryker
Stryker Xia 3 Power Adaptor from Stryker Spine
Firebird SI Fusion System from Orthofix
HydroCision SpineJet System from HydroCision
SpineEx Sagittae Lateral Lumber Interbody Fusion Devices from SpineEX
Tiger Occipital-Cervical-Thoracic Spinal Fixation System from CoreLink
SI-Restore Sacroiliac Joint Fusion System from Biofusion Medical
Solstice CCI from Life Spine
May
MiRus 3DPrinted Lumbar Interbody Fusion Systems from MiRus
Precice Bone Transport System from NuVasive Specialized Orthopedics
VADERone Pedicle System MIS and LightMore Pedicle System 6.0 from Icotec
Audere Lumbar Spacer System from Met One Technologies
Precice Screws from NuVasive Specialized Orthopedics
Anterior Spine Truss System – Stand Alone Interbody Fusion Device from 4Web
Reform Pedicle Screw System from Precision Spine
Axis Spine Technologies ALIF from Axis Spine Technologies
Rosa One Brain application from Medtech
Perla Posterior Occipito-Cervico-Thoracic Fixation System from Spineart
Meridian Anterior Plate System, Regatta Lateral Plate System from SeaSpine Orthopedics
Mazor X from Mazor Robotics
Invictus CT Spinal Fixation System from Alphatec Spine
NuVasive Thoracolumbar Plates from NuVasive
Nexxt Matrixx System from Nexxt Spine
Evol Spinal Interbody System from Cutting Edge Spine
Insignia Anterior Cervical Plate System from Alphatec Spine
NuVasive ACP System from NuVasive
Cure Lumbar Plate System from Meditech Spine
June
Spinal Fixation System from Shangdong Kangsheng Medical Device
SpineFrontier Lumbar Interbody Fusion Device System from SpineFrontier
F3D Cervical Stand-Alone Interbody Fusion System from CoreLink
Medussa-PL Cage from Medyssey USA
IlluminOss Bone Stabilization System from IlluminOss Medical
Altus Spine Pedicle Screw System from Altus Partners
Rigel 3DR Anterior Cervical Interbody Fusion System from MiRus
SeaSpine Meridian System, SeaSpine Regatta Lateral System from SeaSpine Orthopedics
Sapphire Spinal System, Sapphire X Anterior Cervical Plate Spinal System from Spinal Elements
Centurion POCT System from Orthofix
July
AccelFix Lumbar Plate System from L&K Biomed Co
Joimax Intracs System from joimax GmbH
Magec System from NuVasive Specialized Orthopedics
Sterispine PS System from Safe Orthopaedics
August
Nadia SI Fusion System from Ilion Medical
Orion Spinal System from Orion Biotech
Mondrian Lumbar Interbody Fusion Cage System from CTL Medical Corp.
GS Medical AnyPlus PEEK Cage System from GS Medical
Modulif-A Anterior Lumbar Interbody Fusion System from Spinal Stability
K2M Navigation Instruments from Stryker
Aurora Anterior Lumbar Plate System from Prism Surgical Design
Adaptix Interbody System with Titan nanoLOCK Surface Technology from Medtronic Sofamor Danek
CD Horizon Fenestrated Screw Set, System, Kyphon HV-R Bone Cement from Medtronic
Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer from Life Spine
Medina Anterior Cervical Plate System from Alliance Partners
Monterey AL Interbody System from Stryker
CoFix System from Paradigm Spine
Confidence Spinal Cement System from DePuy Spine
CarboClear Pedicle Screw System, CarboClear II Pedicle Screw System from CarboFix Orthopedics
Cervical Plate System from Eminent Spine
September
Cavetto-SA Cervical Cage System from NeuroStructures Inc.
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle from Becton, Dickinson and Co.
WaveForm C Interbody System from SeaSpine
Talos-C Cervical Intervertebral Body Fusion System from Meditech Spine
Simpact Sacroiliac Joint Fixation System from Life Spine
Shoreline Anterior Cervical System from SeaSpine
Firebird SI Fusion System from Orthofix
TruLift Expandable Spacer System from Life Spine
NuVasive Thoracolumbar Interbody Systems from NuVasive
Struxxure-L and Struxxure-A Plate System from Nexxt Spine
Artus cervical plate system from Ulrich GmbH & Co. KG
October
Hexanium ACIF from SpineVision
Zavation IBF system from Zavation Medical Products
Unid IB3D ALIF from Medicrea
LnK spinal fixation system, OpenLoc-L spinal fixation system from L&K Biomed
MySpine S2-Alar/Alar Ilar-Iliac pedicle screw placement guides from Medacta
LnK posterior cervical fixation system and CastleLoc-S posterior cervical fixation from L&K Biomed
AccelFix spinal fixation system from L&K Biomed
NuVasive Cohere thoracolumbar interbody system from NuVasive
Trivergent spinal fixation system from Benvenue Medical
Fortilink cages with TiPlus technology from Paradigm Spine
Icotec anterior cervical plate system from Icotec AG
Kheiron spinal fixation system from Smaio
NuVasive Modulus XLIF interbody system from NuVasive
Gaia lumbar interbody fusion device from PriterPrezz
Oculus-SA lumbar cage system from Neurostructures
Atlas spine rebar spacer system from Atlas Spine
Epic anterior thoracolumbar plate system from Zimmer Biomet Spine
Invictus OsseoScrew System from Alphatec Spine
SpineJack expansion kit from Stryker
Anthem Fracture System from Globus Medical
Cannulated power driver attachment from K2M
Construx mini PTC spacer system from Orthofix
OsteoMed ExtremiFix mini and small cannulated screw system from Osteomed
Wiltrom spinal fixation system from Wiltrom
Construx Mini PEEK spacer system from Orthofix
Mazor X from Mazor Robotics