510(k) Report

Devices descending from K993465

42 later devices reach Depuy Ace Calcaneal Peri-Articular Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH2005281
+1K041786Calcamea PlateNew Deal, S.A.200413—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K090582Calcaneal Fracture Plate SystemTornier, Inc.200912—
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+2K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—