510(k) Report

Devices descending from K953877

572 later devices reach Mitek Gii Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+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—
+10K140769Variax 2 SystemStryker Trauma AG201419—
+11K262975Arthrex Beaming SystemArthrex, Inc.20260—
+11K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+11K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K240194ProCinch, QuadCinchRiverpoint Medical20240—
+11K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+11K233552IDEAL ZiploopRiverpoint Medical20230—
+11K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+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—
+12K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+12K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+12K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+12K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+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—
+13K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+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—