510(k) Report

Devices descending from K060336

91 later devices reach Navitrack System-OS Knee Universal, Model Pro-05002 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110054Navitrack System - OS Knee Universal, Cas Same Incision Tibia ReferenceZimmer Cas201192
+1K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+1K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+2K202750Knee+Pixee Medical20218—
+2K121936NaviopfsBlue Belt Technologies, Inc.2012222
+2K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101—
+2K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+3K220104Knee+Pixee Medical20227—
+3K140596NAVIOBlue Belt Technologies, Inc.201421—
+3K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+4K232176STELLAR KneePolarisar, Inc.20230—
+4K230789Knee+Pixee Medical20235—
+4K143668NavioBlue Belt Technologies, Inc.201520—
+4K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+4K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+4K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+5K233899Knee+Pixee Medical20244—
+5K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+5K152574NavioBlue Belt Technologies, Inc.201519—
+5K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+5K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+5K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+5K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+6K243975Knee+Pixee Medical20253—
+6K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+6K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+6K160537NavioBlue Belt Technologies, Inc.201618—
+6K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+7K253805Knee+Pixee Medical S.A.S.20260—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+7K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+7K170360NAVIOBlue Belt Technologies, Inc.201717—
+7K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+8K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+8K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+8K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+9K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+9K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+9K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+9K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+9K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+9K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+9K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+9K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+9K191223NAVIOBlue Belt Technologies, Inc.201915—
+10K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+10K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+10K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+10K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+10K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+11K252847NextAR Hip PlatformMedacta International S.A.20260—
+11K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+11K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+11K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+11K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+12K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+12K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+12K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+13K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+13K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+13K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+14K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+14K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+14K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+14K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+15K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+15K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+15K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+16K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+16K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+16K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+16K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+16K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+17K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+18K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+19K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601