510(k) Report

Devices descending from K083644

13 later devices reach Mako Surgical Tactile Guidance System-Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+2K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+3K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—