510(k) Report

Devices descending from K914558

29 later devices reach Traumafix (TM) External Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes201332
+1K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc.199717—
+1K960297Mandibular Bone Distractor IIHowmedica Corp.199623—
+2K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+2K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc.20141—
+2K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+2K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P.20043—
+2K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026—
+2K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997—
+2K984117Innova Telescopic DistractorInnova Corp.19990—
+2K981362Synthes (Usa) External Multi Vector Mandible DistractorSynthes (Usa)19985—
+2K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.199711—
+2K972154Cohen DistractorHowmedica Leibinger, Inc.19978—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—
+3K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+3K133398Stryker Pediatric Mandible DistractorStryker20141—
+3K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+3K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+3K063792Osteomed External Mandibular Distraction SystemOsteomed LP20072—
+3K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+3K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP20030—
+3K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+3K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc.19981—
+3K973484Chin DistractorHowmedica, Inc.19971—
+4K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—
+4K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP20131—
+4K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+4K030790Osteomed Alveolar Distraction SystemOsteomed LP20030—
+5K230211CranioXpandKLS-Martin L.P.20230—