510(k) Report

Devices descending from K961522

439 later devices reach Kirschner Wire (K-Wire) and Steinmann Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K262975Arthrex Beaming SystemArthrex, Inc.20260—
+9K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+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—
+9K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K240194ProCinch, QuadCinchRiverpoint Medical20240—
+9K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+9K233552IDEAL ZiploopRiverpoint Medical20230—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K230212OrthoButton ALRiverpoint Medical, LLC20232—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K202399OrthoButton FLRiverpoint Medical20201—
+9K173135VariAx 2 SystemStryker GmbH201713—
+9K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+10K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+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—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+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—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+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—