510(k) Report

Devices descending from K902307

226 later devices reach Shaw II Hemostatic Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP20233—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K093914Newdeal Compression PlatesNewdeal Sas2011985
+5K091609Newdeal Compression PlateNewdeal Sas200921
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+7K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221395Footmotion Plating SystemNewclip Technics20220—
+8K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+8K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+8K161448Footmotion Plating SystemNewclip Technics20165—
+8K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+8K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+8K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+8K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+8K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+9K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+9K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+9K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+9K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K200062Foot and Ankle SystemLeith Medical, LLC20210—
+9K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+9K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+9K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+9K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+9K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+9K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+9K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+9K172886Breakaway Screw SystemParagon 2820174—
+9K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+9K171510Footmotion Plating SystemNewclip Technics20171—
+9K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+9K170843Alians Fragment SpecificNewclip Technics20171—
+9K170012Foot and Hand MotionNewclip Technics20170—
+9K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+9K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+10K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+10K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+10K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—