510(k) Report

Devices descending from K011334

798 later devices reach Synthes Curved Reconstruction Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203381Dynanail Mini HybridMedShape, Inc.202141
+8K202810AutoStrut G2Orthospin, Ltd.20213—
+8K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+8K193366T2 ICFStryker GmbH20201—
+8K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+8K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+8K190830TDM Screw SystemsTdm Co., Ltd.20191—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K173641Activ AnkleNewclip Technics20183—
+8K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+8K170771VariAx 2 Foot SystemStryker GmbH20170—
+8K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+8K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+8K151769Anchorage 2 CP SystemStryker GmbH20150—
+8K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+8K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+9K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+9K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K231860TDM Screw SystemTdm Co., Ltd.20240—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+9K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+9K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+9K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+9K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+9K191009Arsenal Plating SystemTrilliant Surgical20192—
+9K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+9K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+9K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+10K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242861TrueLok ElevateOrthofix Srl20243—
+10K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+10K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+10K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—