510(k) Report

Devices descending from K970617

380 later devices reach CT-Modeller System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210344inVisionOSPrecisionos Technology, Inc.20210—
+7K203486OtoplanCascination AG20212—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K192038Emprint Visualization ApplicationCovidien, LLC20191—
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K172418OpenSightNovarad Corporation20185—
+7K173274Ceevra Reveal 2.0Ceevra, Inc.201817—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+8K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+8K252064MedCAD® AccuStride™ SystemMedcad20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K253793Materialise TKA Guide SystemMaterialise NV20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251709MedCAD® AccuStride™ SystemMedcad20250—
+8K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics20250—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K242120OtoplanCascination AG20250—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K233925Relu CreatorRelu BV20246—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K222035Avatar Medical Software V1Avatar Medical20232—
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K222676Ceevra Reveal 3Ceevra, Inc.20235—
+8K222458Aibolit 3D+Aibolit Technologies, LLC20230—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+8K220300OtoplanCascination AG20220—
+8K220146VisARNovarad Corporation20220—
+8K211443Aibolit 3D+Aibolit Technologies, LLC20222—
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K192890SentEPSentiar, Inc.20201—
+8K182643IRIS 1.0 SystemIntuitive Surgical20192—
+9K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC20260—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260785DS Core CBCT AnatomyDentsply Sirona20261—
+9K253950Avatar Medical VisionAvatar Medical20260—
+9K252538CEPHX3DOrca Dental AI, Ltd.20260—
+9K252091Surgical Reality ViewerMedicalvr B.V.20260—
+9K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K243989Second Opinion® 3DPearl, Inc.20253—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K242205SpectoMed (v1.0)Specto Medical20250—
+9K242461IRISegIntuitive Surgical, Inc.20241—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K232339Augmented Reality ApplicationSira Medical, Inc.20240—
+9K233568Ceevra Reveal 3+Ceevra, Inc.20232—
+9K232189OrionXRHoth Intelligence, Inc.20230—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc.20230—
+10K262127DS Core CBCT AnatomyDentsply Sirona20260—
+10K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—
+10K251763IRISegIntuitive Surgical, Inc.20250—
+10K243933Ceevra Reveal 3+Ceevra, Inc.20251—
+11K261595Ceevra Reveal 4Ceevra, Inc.20260—