510(k) Report

Devices descending from K951262

232 later devices reach Operating Arm System (Oas) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964801Optical Tracking System (Ots)Radionics Software Applications, Inc.19973—
+1K961834Philips Easyguide NeuroPhilips Medical Systems, Inc.19960—
+1K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc.1996158—
+1K960714Isg Viewing WandI.S.G. Technologies, Inc.199671—
+2K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc.1999152—
+2K990632Optical Tracking System (Ots)Radionics, Inc.19990—
+2K984398Liquichek Ana Control, Homogeneous Pattern, Model 201Bio-Rad19980—
+2K974602Optical Tracking System (Ots)Radionics Software Applications, Inc.19982—
+2K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB19981—
+2K964229Regulus NavigatorCompass Intl., Inc.199766—
+2K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc.19973—
+3K133573Fiagon Navigation SystemFiagon GmbH201428—
+3K013025Modification to Flourolab PlusZ-Kat, Inc.2001151—
+3K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB19990—
+3K981480Philips EasyguidePhilips Medical Systems, Inc.19990—
+3K983669Optical Tracking System with Surface Matching Module, Model OtsRadionics, Inc.19980—
+3K981315NavitrackOrthosoft, Inc.199836—
+4K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+4K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+4K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+4K162176Fiagon Navigation SystemFiagon GmbH20164—
+4K161701CARTO ENT SystemBiosense Webster20163—
+4K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+4K150473FlexPointer 1.5 mmFiagon GmbH20152—
+4K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+4K031454Acumen Surgical Navigation SystemBiomet, Inc.2004146—
+4K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+4K031732Ebi Acumen Surgical Navigation SystemEbi, L.P.20030—
+4K031337Acumen Surgical Navigation SystemBiomet, Inc.200381—
+5K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+5K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+5K201174TruDi CuretteAcclarent, Inc.20200—
+5K193453TruDi ProbeAcclarent, Inc.20200—
+5K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+5K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+5K192397TruDi Navigation SystemBiosense Webster202011
+5K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+5K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+5K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+5K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+5K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+5K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+5K160369GuideWireFiagon GmbH20163—
+5K111863Signature Planner,Signature GuidesMaterialise NV201271—
+5K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+5K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+5K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+5K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+5K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+5K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+6K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+6K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+6K190532TruDi NAV WireAcclarent, Inc.20190—
+6K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+6K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+6K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+6K140596NAVIOBlue Belt Technologies, Inc.201421—
+6K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+6K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+6K121936NaviopfsBlue Belt Technologies, Inc.2012222
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+6K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+6K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+6K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+6K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+7K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K202484Cordera Hip SystemConformis, Inc.202022
+7K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+7K192198Conformis Hip SystemConformis, Inc.2019121
+7K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+7K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+7K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+7K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+7K143668NavioBlue Belt Technologies, Inc.201520—
+7K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+7K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+7K110911Renaissance SystemMazor Robotics, Ltd.201124—
+7K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+8K221104Actera™ hip systemConformis, Inc.202211
+8K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+8K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K190738MyShoulder Placement GuidesMedacta International S.A.20194—