510(k) Report

Devices descending from K862807

490 later devices reach Treace Drill System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964548Apex Universal Drive SystemLinvatec Corp.1997489—
+2K971059Universal Drive SystemLinvatec Corp.1997488—
+3K072706Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed…Conmed Linvatec20073—
+3K070233Conmed Linvatec Smart Guard IrrigatorConmed Linvatec20070—
+3K060198Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and…Linvatec Corp.20065—
+3K060260Micropower Hand Piece High Speed DrillLinvatec Corp.20065—
+3K060270Micropower Hand Piece: Oral Max High Speed DrillLinvatec Corp.20065—
+3K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc.20010—
+3K012613Reprocssed Linvatec ShaversAlliance Medical, Inc.200101
+3K012536Reprocessed Powered Arthroscopic AccessoriesSterilmed, Inc.20011—
+3K990524E9000 SystemLinvatec Corp.1999477—
+3K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998478—
+3K981269Universal Drive SystemLinvatec Corp.199823
+4K113028Medisiss Reprocessed Arthroscopic Shavers and BursMedisiss20110—
+4K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+4K083284Piezosurgery MedicalPiezosurgery S.R.L.20099—
+4K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec20099—
+4K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec20080—
+4K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme20062—
+4K060172Rema Shaver BladesRema Medizintechnik GmbH.20060—
+4K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical20060—
+4K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001447—
+4K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001447—
+4K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001446—
+5K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+5K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+5K132848Piezosurgery FlexMectron S.P.A.20136—
+5K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+5K100410Piezoelectric SystemSatelec20108—
+5K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.20084433
+5K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20084201
+5K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+6K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+6K233958hekaDrillZethon, Ltd.20240—
+6K193630hekaDrillZethon, Ltd.20210—
+6K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+6K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+6K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+6K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+6K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+6K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+6K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+6K153743Piezosurgery PlusMectron S.P.A.20162—
+6K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+6K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMedtronic Xomed, Inc.20150—
+6K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+6K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+6K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+6K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+6K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+6K133061Espin SystemNlt Spine, Ltd.20130—
+6K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+6K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+6K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+7K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+7K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K232684Surgify HaloSurgify Medical OY20233—
+7K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+7K231126Eblator DeviceE Surgical, LLC20231—
+7K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+7K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+7K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+7K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+7K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+7K202120P300 AttachmentNakanishi, Inc.20211—
+7K210637CD Horizon™ Spinal SystemMedtronic202134—
+7K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+7K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+7K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+7K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—
+7K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—
+7K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+7K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+7K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+7K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+7K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+7K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+8K252662UniBurNakanishi, Inc.20250—