510(k) Report

Devices descending from K112507

46 later devices reach Restoris Partial Knee Application (Pka), Rio Standard System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+1K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+1K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+2K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+2K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+2K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+2K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+3K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+3K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+3K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+4K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+4K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+4K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+5K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+5K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+5K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+5K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+5K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+5K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+5K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+5K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+5K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+6K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+6K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+6K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+7K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+10K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+11K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+12K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+13K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+14K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+15K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601