510(k) Report

Devices descending from K992961

378 later devices reach Lorenz Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+7K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+7K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+7K240487EVOS Patella PlatesSmith & Nephew20240—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+7K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+7K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+7K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+7K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+7K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K213214Xpert WristNewclip Technics20210—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+7K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+7K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+7K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K191867ATLAS Plating SystemMiRus, LLC20200—
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+7K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+7K190830TDM Screw SystemsTdm Co., Ltd.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+7K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+7K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+7K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+7K173641Activ AnkleNewclip Technics20183—
+7K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+7K172350AxSOS 3 TiStryker GmbH201717—
+7K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+7K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+7K171510Footmotion Plating SystemNewclip Technics20171—
+7K170843Alians Fragment SpecificNewclip Technics20171—
+7K170771VariAx 2 Foot SystemStryker GmbH20170—
+7K170012Foot and Hand MotionNewclip Technics20170—
+7K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+7K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+7K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+7K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+7K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+7K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+7K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+7K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+7K151769Anchorage 2 CP SystemStryker GmbH20150—
+7K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+7K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+7K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+7K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K262344Large Compression ScrewsTriMed, Inc.20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K261241TriMed Compression ScrewsTriMed, Inc.20260—
+8K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—