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Year in Review

Companies Receiving First Orthopaedic-related 510(k) Clearances in 2011

For complete information  on these strategic 510(k) filings, please visit FDA’s 510(k) Premarket Notification Database online at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.


4-Web Spine
ALIF Spinal Truss Interbody Fusion Device, K083894

Aaxter
www.aaxter.com
A3 Posterior Spinal Pedicle Screw, K101374

Algea Therapies (Affiliated with Globus Medical)
Affirm Vertebral Compression Fracture System, K110998

Apex Tools & Orthopedics
www.apextooltool.com
Kirschner Wires and Steinmann Pins, K112254

Arrowhead Medical Device Technologies
www.arrowheaddevices.com
Arrow-Lok Digital Fixation System, K112675

Aston Medical
www.aston-medical.com
Duocentric Reversed Shoulder, K103251

BM Korea
Gyeonggi-do, Republic of Korea
www.bmkmedi.com
Guardian Inflatable Bone Expander System, K111593

Bright Spine
www.brightspine.com
Galileo Spinal Spacer, K102449

CarboFix Orthopedics
www.carbo-fix.com
Piccolo Composite Nailing System, K111056

Cardinal Spine
STCC Intervertebral Fusion Device, K100698

CoAlign Innovations
www.coalign.com
AccuLIF Cage, K110270

Cutting Edge Spine
Interbody Fusion Device, K102957

Dallen Medical
www.dallenmedical.com
Compressyn Band, K101484

Double Engine Medical Material
www.demm.cn
Locking Plate and Screw, K112819

Eisertech
www.eisertech.com
Cervical Cage, K110915

Ellipse Technologies
www.ellipse-tech.com
Intramedullary Limb Lengthening System, K101997

ExtraOrtho
www.qfxtechnologies.com
Xtrafix External Fixation System, K111155

FX Solutions
Humelock Cemented Shoulder, K111097 

Icotec
www.icotec.ch
ETurn Spinal Implant, K100305

Implanova
www.implanova.com
X-ing Spine Fixation System, K111995

Intuitive Spine
www.intuitivespine.com
Discovery Intervertebral Fusion Device, K111484

Kalitec Direct
Odalys Pedicle Screw, K111370

Konigsee Implantate
www.koenigsee-implantate.de
SFC Vertebral Body Replacement, K110153

Medical Concepts
www.medicalconcepts.net
Interbody Fusion System, K110659

Mediscope Manufacturing
www.mediscope-mfg.com
Compression Staple and Accessories, K102387

Medisiss
www.medisiss.com
Reprocessed Arthroscopic Shaver, K113028

Nanovis
www.nanovisinc.com
Intervertebral Body Fusion System, K110442

Nextremity Solutions
www.nextremitysolutions.com
FlexFusion Fixation Implant, K110445

NLT Spine
www.nlt-spine.com
Prow Intervertebral Fusion Device, K112359

Ortho Kinematics
www.orthokinematics.com
Kinegraph VME Software, Motional Normalizer Patient Handling and Data Collection Device, K112109

Osteospring Medical
www.osteospring.com
Footjack Subtalar Implant, K112658

Phygen
www.phygenspine.com
Leucadia Pedicle Screw, K103102

Pinnacle Spine
www.pinnaclespinegroup.com
Infill Intervertebral Body Fusion Device, K103729

Pivot Medical
www.pivotmedical.com
NanoTack Suture Anchor, K110473

Rhausler Spinal Implants
www.rhausler.com
Plage Anterior Cervical Fusion System, K111272

RoG Sports Medicine
www.buyrog.com
Suture Anchor, K110229 and Knotless Suture Anchor, K110230

Safe Orthopaedics
www.safeorthopaedics.com
SteriSpinePS Pedicle Screw, K112453

Shoulder Innovations
www.shoulderinnovations.com
Total Shoulder System, K102670

Shoulder Options
www.shoulderoptions.com
Cuff Repair Plate, K102539

Soteira
www.soteira.com
Shield Kyphoplasty System, K093477

Spinal Solutions
Lancer Pedicle Screw, K110633

SpineNet
www.spinenetllc.com
Daytona Anterior Cervical Cage, K110733

Stanmore Implants
www.stanmoreimplants.com
JTS Extendable Implant, K092138

Synovis Orthopedic and Woundcare
www.synovisorthowound.com
PRO Fixation System, K110538

Tarsus Medical
www.tarsusmedical.com
Meta-Lock Suture Anchor, K110800

Technologia Y Diseno Industrial
www.tdi-sa.com
NewFix External Fixation System, K101338

TGM Medical (Affiliated with Consensus Orthopedics)
Helicon Hip System, K111472

Thompson MIS
www.thompsonmis.com
Bonebac T-PLIF Intervertebral Body Fusion System, K111512

Zavation
Pedicle Fixation System, K112484