510(k) Report

Devices descending from K930892

598 later devices reach Mitek Mini Anchor, Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+10K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+10K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+10K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+10K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+10K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+10K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+10K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+10K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+10K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+10K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+10K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+10K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+10K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+10K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+10K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+10K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+10K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+10K173556Injection ScrewBiedermann Medtech, Inc.20180—
+10K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+10K171060OrthoButton ALRiverpoint Medical20178—
+10K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+10K140769Variax 2 SystemStryker Trauma AG201419—
+11K262975Arthrex Beaming SystemArthrex, Inc.20260—
+11K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+11K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+11K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+11K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K240194ProCinch, QuadCinchRiverpoint Medical20240—
+11K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+11K233552IDEAL ZiploopRiverpoint Medical20230—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K230212OrthoButton ALRiverpoint Medical, LLC20232—
+11K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+11K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+11K202399OrthoButton FLRiverpoint Medical20201—
+11K173135VariAx 2 SystemStryker GmbH201713—
+11K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+12K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+12K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+12K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+12K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+12K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+12K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+12K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+12K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+12K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+12K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+12K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+12K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+12K180500VariAx 2 SystemStryker GmbH201812—
+13K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+13K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+13K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+13K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+13K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+13K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+13K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+14K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+14K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+14K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+15K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+15K233919VariAx 2 Distal Radius SystemStryker GmbH20242—