510(k) Report

Devices descending from K070108

33 later devices reach Elibra Dynamic Knee Balancer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132104Elibra Soft-Tissue Force SensorKamm & Associates201413—
+1K093046Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different SizesSynvasive Technology, Inc.20110—
+1K090474Orthorex Intra-Operative Load SensorOrthosensor, Inc.200930—
+2K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+2K150372VERASENSE Knee SystemOrthosensor, Inc.201627—
+2K130380Orthosensor Knee BalancerOrthosensor, Inc.2013291
+3K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+3K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc.201856
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K131767Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc.201328—
+4K241298QuadsenseEventum Orthopaedics, Ltd.20241—
+4K231172ApolloKneeCorin U.S.A. Limited20230—
+4K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+4K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm…Orthosensor, Inc.20200—
+4K200665VERASENSE for Stryker TriathlonOrthosensor, Inc.20200—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+5K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+5K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.20250—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+5K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+5K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+6K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+6K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+7K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—