510(k) Report

Devices descending from K070955

188 later devices reach Acid Etched Lag Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma200818—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+2K102577Force Medical IM Nail SystemForce Medical, Inc.20120—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+3K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+3K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K163589SIGN IM NailSign Fracture Care International20170—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—