510(k) Report

Devices descending from K961497

628 later devices reach Profyle Titanium Hand and Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+6K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+6K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+7K254280F.A.S.T ScrewSteps Ortho20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261191Alians Elbow SNewclip Technics20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+7K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+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—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+7K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+7K191867ATLAS Plating SystemMiRus, LLC20200—
+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—
+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—
+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—
+7K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+7K171510Footmotion Plating SystemNewclip 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—
+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—
+8K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+8K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+8K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+8K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+8K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K231860TDM Screw SystemTdm Co., Ltd.20240—
+8K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+8K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—