510(k) Report

Devices descending from K081700

27 later devices reach Synthes (Usa) Sternal Fixation System - Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC201426—
+2K161590MatrixRIB Fixation SystemSynthes (USA) Products, LLC20163—
+2K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+3K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+3K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+3K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+3K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+3K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+3K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+4K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+4K221412ARIX Rib SystemJeil Medical Corporation20221—
+4K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation20168—
+5K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+5K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+5K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+6K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+6K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+6K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+6K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+6K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—