234 FDA cleared devices from orthopedic & spine device companies so far in 2018

Spinal Tech

Here are 234 orthopedic and spine device companies that received FDA device clearances in 2018 so far.

June

Icotec Interbody Cage System from icotec.

A-CIFT SoloFuse from SpineFrontier.

SeaSpine Navigation System from SeaSpine Orthopedics.

Zimmer Persona Personalized Knee System from Zimmer.

OrthoPediatrics PediNail Intramedullary Platform from OrthoPediatrics.

SpineKure Kyphoplasty System from Hanchang.

Kator Suture Anchor from Kator.

STALIF C FLX from Centinel Spine.

Patriot Colonial Spacer, Sustain Spacer from Globus Medical.

InTice-C Porous Ti Cervical Interbody System from X-Spine Systems.

NuVasive XLX Interbody System from NuVasive.

Legend Acetabular Liners from Ortho Development.

Stylo Interbody Fusion Device from Legend Spine Technologies.

Healix Advance Knotless BR Anchor from Medos International.

Sagico OSI Spinal System by Osimplant from Spinal Analytics.

Additive Orthopaedics Patient Specific 3D Printed Bone Segments from Additive Orthopaedics.

Evolution Knee Systems from MicroPort Orthopedics.

Hexanium TLIF from SpineVision.

Aevumed Phantom Suture Anchors from Aevumed.

Atec Universal Spacer System from Alphatec Spine.

Harrier-SA Lumbar Interbody System from ChoiceSpine.

Guided Growth Plate System Plus from Orthofix.

Pro-Link Ti Stand-Alone Cervical Spacer System from Life Spine.

Arthrex FastThread Interference Screw from Arthrex.

SeaSpine Daytona Small Stature Spinal System from SeaSpine Orthopedics.

Reliance Lumbar IBF System from Reliance Medical Systems.

Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

Spineology Navigation Instruments from Spineology.

Omni Foot Plating System from Extremity Medical.

Aerial Interspinous Fixation from Globus Medical.

DTRAX Spinal System from Providence Medical Technology.

EVOL Spinal Interbody System from Cutting Edge Spine.

ConforMIS iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

Klassic HD Hip System from Total Joint Orthopedics.

Diamond Orthopedic Bone Fixation Screws and Pins from Diamond Orthopedic.

AlignX Ankle Fusion System from Extremity Medical.

Everest Spinal System from K2M.

May

Icotec Interbody Cage System from icotec ag.

A-CIFT SoloFuse from SpineFrontier.

SeaSpine Navigation System from SeaSpine Orthopedics.

Persona Personalized Knee System from Zimmer.

OrthoPediatrics PediNail Intramedullary Platform from OrthoPediatrics.

SpineKure Kyphoplasty System from Hanchang.

Stalif C FLX from Centinel Spine.

Patriot Colonial Spacer, Sustain Spacer from Globus Medical.

InTice-C Porous Ti Cervical Interbody System from X-Spine Systems.

NuVasive XLX Interbody System from NuVasive.

Legend Acetabular Liners from Ortho Development Corp.

STYLO Interbody Device from Legend Spine Technologies.

SAGICO OSI Spinal System by Osimplant from Spinal Analytics & Geometrical Implants.

Additive Orthopaedics Patient Specific 3D Printed Bone Segments from Additive Orthopaedics.

Evolution Knee Systems – MR Labeling, Evolution Biofoam Tibial System from MicroPort Orthopedics.

Hexanium TLIF from SpineVision.

Harrier-SA Lumbar Interbody System from ChoiceSpine.

Guided Growth Plate System Plus from Orthofix.

Pro-Link Ti Stand-Alone Cervical Spacer System from Life Spine.

Arthrex FastThread Interference Screw from Arthrex.

SeaSpine Daytona Small Suture Spinal System from SeaSpine Orthopedics.

Reliance Lumbar IBF System from Reliance Medical Systems.

Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

Omni Foot Plating System from Extremity Medical.

Aerial Interspinous Fixation from Globus Medical.

DTRAX Spinal System from Providence Medical Technology.

EVOL Spinal Interbody System from Cutting Edge Spine.

ConforMIS iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

Klassic HD Hip System from Total Joint Orthopedics.

Diamond Orthopedic Bone Fixation Screws and Pins from Diamond Orthopedic.

AlignX Ankle Fusion System from Extremity Medical.

Navigated Infinity Instruments from Medtronic Sofamor Danek USA.

Everest Spinal System from K2M.

April 

Corin Optimized Positioning System Plan from Corin USA.

Reform POCT System from Precision Spine.

Infinity Total Ankle System from Wright Medical.

Agile Nail from Orthofix.

Half Dome Posterior Lumbar Interbody System from Astura Medical.

Mercury Spinal System from Spinal Elements.

Unity Sacroiliac Joint Fixation System from Huvexel.

Enza-A Titanium ALIF from Camber Spine Technologies.

MySpine Pedicle Screw Placement Guides from Medacta International.

LigaPASS from Medicrea International.

SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device from SeaSpine.

A.L.P.S. Clavicle Plating System from Biomet.

UNiD Patient Specific 3D printed cage from Medicrea International.

Axis Anterior Cervical Plate System from Axis Orthopaedics.

Corin TriFit CF Hip System from Corin USA.

Genesys Spine Binary Lumbar Plate System from Genesys Spine.

Arthrex Univers Revers Modular Glenoid System from Arthrex.

Mediant Anterior Cervical Plating System from Intelligent Implant Systems.

OVOMotion Shoulder Arthroplasty System from Arthrosurface.

Rampart One Lumbar Interbody Fusion Device from Spineology.

Fibergraft BG Matrix Bone Graft Substitute from Prosidyan.

Medacta Shoulder System Short Humeral Diaphysis from Medacta International.

Cure Lumbar Plate System from Meditech Spine.

Creo Stabilization System from Globus Medical.

Navio Surgical System from Blue Belt Technologies.

InCore Lapidus System from Nextremity Solutions.

Axis 5.5 Lumbar pedicle Screw System from Axis Orthopaedics.

Mazor X from Mazor Robotics.

Patriot Spinal Fixation System from Valorus Spine.

K2M Patient Specific Rods from K2M.

Focus Pedicle Screw System from Nvision Biomedical Technologies.

Precice Stryde System from NuVasive Specialized Orthopedics.

Stablyx Arthroplasty Implant System from Skeletal Dynamics.

World Knee System from Signature Orthopaedics.

Vertex Reconstruction System from Medtronic Sofamor Danek.

March

Puma System from Panther Orthopedics.

HammerToe System from Paragon 28.

TDM Plate and Screw System from TDM.

Arthrex Shoulder System from Arthrex.

Mpact 3D Metal Implants and Augments 3D Metal from Medacta.

Navigated Instrument System from Orthofix.

Anchorage Bone Plating System from Stryker.

CoreHip System from Aesculap Implants Systems.

Irene Thoracolumbar Fixation System from Tianjin Zhengtian Medical Instruments.

Fortress Radiopaque Bone Cement, Creo Fenestrated Screw System, Revlok Fenestrated Screw System from Globus Medical.

Arthrex Univers Revers Coated Baseplate from Arthrex.

Footmotion HammerToe from Newclip Technics.

DePuy Synthes Femoral Neck System from DePuy Synthes.

Zimmer Knee Joint Replacement Prostheses MR Labeling from Zimmer.

Arco-SA Lumbar Cage System from NeuroStructures.

Sentio MMG Pedicle Access Needless from Medos International.

Mega Plus Spine System from BK Meditech.

CD Horizon Spinal System from Medtronic Sofamor Danek.

Exactech Equinoxe Stemless Shoulder from Exactech.

Valeo C+CSC with Lumen Interbody Fusion Device from Amedica.

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads from Stryker.

Exactech Novation and AcuMatch E-HXL Acetabular Liners from Exactech.

Empor Universal Tibial Baseplate from Encore Medical.

SI Screw System from Zavation Medical Products.

Arthrex Corkscrew from Arthrex.

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared from Medacta.

Triway Tibiotalocalcaneal Arthrodesis System from In2Bones.

Catalyst CSR 3 Peg Glenoids from Catalyst OrthoScience.

Genesys Spine AIS-C Cervical Anchored Interbody System from Genesys Spine.

X-spine Cortical Bone Screw System from X-spine Systems.

SP-Fix Spinous Process Fixation Plate, Relieve Laminoplasty Fixation System from Globus Medical.

Klassic Knee System from Total Joint Orthopedics.

NuVasive VuewPoint II OCT System from NuVasive.

Polaris Spinal Growth System from Zimmer Biomet Spine.

Ventix Link Knotless Anchor with Inserter from Cayenne Medical.

Legion Knee System from Smith & Nephew.

Cortina Lumbar Cage System from NeuroStructures.

CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva Spine.

Zavation Buttress Plate System from Zavation Medical.

G-scan Brio from Esaote.

February
Zyston Strut Open Titanium Spacer System from Zimmer Biomet.

Tryptik2 C-Plate Anterior Cervical Plate System from Spineart.

The Plateau-LO Spacer System from Life Spine.

G-Beam Fusion Beaming System from Orthofix.

Cascadia Interbody System from K2M.

NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System; NuVasive AP Expandable XLIF System from NuVasive.

The Solstice OCT System from Life Spine.

Cavetto-SA Cervical Cage System from NeuroStructures.

Seurat Universal Pedicle Screw System from CTL Medical Corporation.

Talon DistalFix Humeral Nail from Orthopedic Designs North America.

Alta Anterior Cervical Interbody Spacer from Astura Medical.

SeaSpine Spinous Process System from SeaSpine Orthopedics.

Comprehensive Segmental Revision System from Zimmer Biomet.

Materialise TKA Guide System from Materialise.

RTS Lesser MTP Implant System from In2Bones USA.

Endoskeleton TAS Interbody Fusion, Endoskeleton TAS Hyperlordotic Interbody Fusion Device from Titan Spine.

Concorde Lift from Medos International.

Camber Spine Technologies Spira-V Open Matrix Corpectomy Cage from Camber Spine Technologies.

THP Hip Fracture Plating System from Zimmer Biomet.

Triathlon Total Knee System from Stryker Orthopaedics.

SeaSpine Mariner Pedicle Screw System from SeaSpine Orthopedics.

Remedy Acetabular Cup from Osteoremedies.

UNiD Spine Analyzer from Medicrea International.

Arthrex NanoSuture Anchor from Arthrex.

Eleos Bipolar Acetabular System from Onkos Surgical.

SeaSpine NewPort Spinal System from SeaSpine Orthopedics.

Tryptik2 C-Plate Anterior Cervical Plate System from Spineart.

The Plateau-LO Spacer System from Life Spine.

Cascadia Interbody System from K2M.

NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System; NuVasive AP Expandable XLIF System from NuVasive.

The Solstice OCT System from Life Spine.

Cavetto-SA Cervical Cage System from NeuroStructures.

Seurat Universal Pedicle Screw System from CTL Medical Corp.

Alta Anterior Cervical Interbody Spacer from Astura Medical.

SeaSpine Spinous Process System from SeaSpine Orthopedics.

Endoskeleton TAS Interbody Fusion, Endoskeleton TAS Hyperlordotic Interbody Fusion Device from Titan Spine.

Camber Spine Technologies Spira-V Open Matrix Corpectomy Cage from Camber Spine Technologies.

SeaSpine Mariner Pedicle Screw System from SeaSpine Orthopedics.

UNiD Spine Analyzer from Medicrea International.

SeaSpine NewPort Spinal System from SeaSpine Orthopedics.

Click here to view FDA approvals from spine companies. 

January

K2M Navigation Instruments from K2M.

Stryker iVAS Elite Inflatable Vertebral Augmentation System from Stryker.

Matisse Anterior Cervical Interbody Fusion Cage System, Ti-PEEK from CTL Medical.

Arbor External Fixation System from Globus Medical.

Spineology Navigation Instruments from Spineology.

Wiltrom Spinal Fixation System from Wiltrom.

TiGer Shark System from ChoiceSpine.

ChoiceSpine Laminoplasty Fixation System from ChoiceSpine.

Cervical Spinal Truss System Interbody Fusion Device from 4Web.

Reliance Lumbar IBF System from Reliance Medical Systems.

Navigated Infinity Instruments from Medtronic Sofamor Danek.

Titanium TL Curved Posterior Lumber Cage from Stryker.

Everest Spinal System from K2M.

SeaSpine Cabo Anterior Cervical Plate System from SeaSpine Orthopedics.

Juliet Ti LL from Spineart.

DeGen Medical E3 MIS Pedicle Screw System from Degen Medical.

Global Unite Platform Shoulder System from DePuy Ireland.

FMS Vue II Fluid Management and Tissue Debridement System from Medos International.

Alians Elbow Locking Plating System from Newclip Technics.

Arrow Reverse Porous Glenoid from Fournitures Hospitalieres Industrie.

Stryker iVAS Elite Inflatable Vertebral Augmentation System from Stryker.

Guided Growth Plate System Plus from Orthofix.

Smith & Nephew Patient Matched Cutting Blocks from Smith & Nephew.

Arbor External Fixation System from Globus Medical.

Bone Screws 6.5mm from Lima Corporate.

Comprehensive Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate from Biomet.

Spineology Navigation Instruments from Spineology.

Wiltrom Spinal Fixation System from Wiltrom.

Forza XP Expandable Spacer System from Orthofix.

T2 Alpha Femur Antegrade GT/PF Nailing System from Stryker Trauma.

ChoiceSpine Laminoplasty Fixation System from ChoiceSpine.

Arthrex PushLock from Arthrex.

Reliance Lumbar IBF System from Reliance Medical Systems.

Evos Small Fragment Upper Extremity Plates from Smith & Nephew.

Ez Plate from Zavation Medical Products.

Navigated Infinity Instruments from Medtronic Sofamor Danek.

Zimmer Persona Personalized Knee System from Zimmer.

Titanium TL Curved Posterior Lumber Cage from Stryker.

Everest Spinal System from K2M.

SeaSpine Cabo Anterior Cervical Plate System from SeaSpine Orthopedics.

DIP Arthrodesis System from I2Bones.

DeGen Medical E3 MIS Pedicle Screw System from Degen Medical.

GENFlex2 Total Knee System – Ultra-Congruent CR Tibial Insert from StelKast.

Unity Total Knee System from Corin USA.

Centurion POCT System from Orthofix.

Click here to see FDA approvals from spine companies. 

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