510(k) Report

Devices descending from K922559

349 later devices reach Acufex Endofix Button through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+8K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+8K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+8K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+8K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K140769Variax 2 SystemStryker Trauma AG201419—
+9K262975Arthrex Beaming SystemArthrex, Inc.20260—
+9K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K173135VariAx 2 SystemStryker GmbH201713—
+9K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+10K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+10K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+10K180500VariAx 2 SystemStryker GmbH201812—
+11K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+11K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+11K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+11K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+12K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+13K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+13K233919VariAx 2 Distal Radius SystemStryker GmbH20242—