510(k) Report

Devices descending from K912932

38 later devices reach Synthes Maxillofacial Titanium Micro Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.200801
+1K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063—
+1K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021—
+1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027—
+1K963502Csco Forehead Fixation SystemHowmedica Corp.19970—
+1K963030Leibinger Imf ScrewHowmedica Leibinger, Inc.199725—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+2K050478Medicon Imf-Orion ScrewsMedicon EG20050—
+2K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050—
+2K050535Stryker MMF ScrewStryker Instruments200511—
+2K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+2K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc.20021—
+2K980760KLS-Martin MMF ScrewKLS-Martin L.P.19998—
+2K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc.19999—
+3K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+3K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+3K121606Resorb-X GKLS-Martin L.P.20130—
+3K122313Stryker Universal Smartlock Hybrid MMF SystemStryker201210—
+3K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+3K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+3K051871Stoma Bone ScrewStorz AM Mark GmbH20051—
+3K042573KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.20044—
+3K040983Lorenz Self-Drilling Imf ScrewWalter Lorenz Surgical, Inc.20047—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+4K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co KG20230—
+4K173320KLS Martin L1 MMF SystemKLS Martin L.P.20182—
+4K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation20155—
+4K141165Matrixwave MMF SystemSynthes (USA) Products, LLC20144—
+4K132212Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX…Hager& Meisinger GmbH20140—
+4K083432Drill Free MMF ScrewKLS Martin L.P.20093—
+5K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+5K233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.20240—
+5K152326Biomet Microfixation OmniMax MMF SystemBiomet Microfixation20151—
+6K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation20210—