510(k) Report

Devices descending from K142923

28 later devices reach TraumaCad Mobile Release 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202519OrthoNext Platform SystemOrthofix Srl20201—
+1K160284JointPointJointpoint, Inc.201621—
+1K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+2K2613522D Hip Planning SoftwareOne Ortho20260—
+2K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+2K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+2K242270OrthoNext Platform SystemOrthofix Srl20240—
+2K231498TraumaCad NeoBrainlab, Ltd.20231—
+2K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+2K203651CuptimizeCuptimize, Inc.20213—
+2K200350MyHip Planner & VerifierMedacta International S.A.20201—
+2K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+2K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+3K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+3K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+3K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K221725Advanced MyHip PlannerMedacta International S.A.20230—
+3K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+3K213922FX SPSPixee Medical20222—
+3K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+3K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+3K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+4K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+4K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+4K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+4K252214AIAS CephalonMetamorphosis GmbH20250—
+4K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+4K242161Radlink GPS Pro ImagingRadlink, Inc.20250—