510(k) Report

Devices descending from K000684

965 later devices reach Small Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203381Dynanail Mini HybridMedShape, Inc.202141
+6K202810AutoStrut G2Orthospin, Ltd.20213—
+6K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K193366T2 ICFStryker GmbH20201—
+6K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+6K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+6K183317AdvantageRib SystemSig Medical Corporation20194—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170771VariAx 2 Foot SystemStryker GmbH20170—
+6K163440Stealth Staple SystemFirst Ray, LLC20173—
+6K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+6K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+6K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+6K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+6K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+6K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+6K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+6K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+6K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+6K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+6K131061Restore Bunion Correction SystemNextremity Solutions201315—
+6K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+6K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+7K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+7K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+7K211843PolyLock Plating SystemFusion Orthopedics20220—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation20213—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915