510(k) Report

Devices descending from K953806

240 later devices reach Synthes (Usa) Midfacial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+1K022185Universal CMF SystemStryker Instruments200233—
+1K983485Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa)1998171—
+1K980199Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa)199810—
+1K974206Synthes Cranial Spring Clip (CSC)Synthes (Usa)19986—
+1K974554Synthes Resorbable Fixation SystemSynthes (Usa)199889—
+1K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.199711—
+1K972154Cohen DistractorHowmedica Leibinger, Inc.19978—
+2K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+2K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.20220—
+2K221855Universal CMF SystemStryker Leibinger GmbH & Co KG20221—
+2K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+2K170773Stryker Universal MeshStryker20171—
+2K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker20170—
+2K171364MP LeFort I PlatesStryker20170—
+2K161821Stryker Universal MeshStryker20162—
+2K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+2K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+2K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa)20101—
+2K100205Frontier Devices Neuro SystemFolsom Metal Products, Inc.20105—
+2K091807Medpor Fixation SystemPorex Surgical, Inc.20100—
+2K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+2K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+2K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical20070—
+2K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+2K032520Ortrautek Trauma SystemTekka20030—
+2K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP20030—
+2K031659Universal Neuro SystemStryker Instruments200312—
+2K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035—
+2K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+2K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027—
+2K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026—
+2K021618Osa Rigid Internal Fixation SystemOsteomed Corp.20026—
+2K021850Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa)200232—
+2K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+2K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+2K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002117—
+2K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+2K994060The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, BiolactateBioplate, Inc.20010—
+2K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+2K982951Imtec BiopinImtec Corp.19990—
+2K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997—
+2K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc.19981—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+2K973484Chin DistractorHowmedica, Inc.19971—
+3K240651MRI UniversalStryker Leibinger GmbH & Co KG20240—
+3K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+3K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG201801
+3K170725Stryker Universal MeshStryker20170—
+3K143338Argulated Locking PlatesOsteomed LP20150—
+3K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+3K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K133398Stryker Pediatric Mandible DistractorStryker20141—
+3K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+3K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+3K112557Stryker Universal Neuro 3 SystemStryker20129—
+3K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+3K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+3K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+3K091686Leforte Neurosystem Bone ScrewJeil Medical Corporation200929—
+3K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+3K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+3K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+3K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+3K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+3K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+3K051871Stoma Bone ScrewStorz AM Mark GmbH20051—
+3K051236Resorb-X SFKLS-Martin L.P.20056—
+3K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+3K031989Ortrautek Orthognathic SystemTekka20035—
+3K030790Osteomed Alveolar Distraction SystemOsteomed LP20030—
+3K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003101—
+3K031751Rapidfire Self Drilling ScrewsWalter Lorenz Surgical, Inc.200301
+3K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+3K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+4K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+4K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+4K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+4K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+4K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+4K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+4K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—
+4K173623Anchor plateBiomaterials Korea, Inc.20180—
+4K170697GBR systemSurgident20182—
+4K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+4K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K132212Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX…Hager& Meisinger GmbH20140—
+4K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+4K131775Universal Neuro 3 SystemStryker20130—
+4K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+4K121606Resorb-X GKLS-Martin L.P.20130—
+4K120352Stryker Quikflap Sterile Procedure PackStryker2012418