510(k) Report

Devices descending from K014263

596 later devices reach Newgen/Universal Mandibular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K141992Variax 2 SystemStryker Trauma AG201422—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+8K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+8K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+8K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K261191Alians Elbow SNewclip Technics20260—
+9K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+9K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+9K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+9K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+9K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+9K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+9K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+9K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+9K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+9K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+9K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+9K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+9K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+9K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+9K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+9K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+9K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+9K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+9K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+9K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+9K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K191867ATLAS Plating SystemMiRus, LLC20200—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+9K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+9K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+9K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+9K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+9K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+9K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+9K190830TDM Screw SystemsTdm Co., Ltd.20191—
+9K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+9K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+9K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+9K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+9K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+9K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+9K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+9K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+9K173641Activ AnkleNewclip Technics20183—
+9K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+9K172350AxSOS 3 TiStryker GmbH201717—
+9K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+9K171510Footmotion Plating SystemNewclip Technics20171—
+9K170771VariAx 2 Foot SystemStryker GmbH20170—
+9K170012Foot and Hand MotionNewclip Technics20170—
+9K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+9K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+9K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+9K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+9K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+9K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+9K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+9K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+9K151769Anchorage 2 CP SystemStryker GmbH20150—
+9K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+9K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+9K143092Tensyn PlugDallen Medical, Inc.20151—
+9K141347Emerge Medical IM Nail SystemEmerge Medical20140—