510(k) Report

Devices descending from K003347

436 later devices reach Orthopilot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+11K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+11K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+11K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+11K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+11K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+11K191223NAVIOBlue Belt Technologies, Inc.201915—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+12K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+12K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+12K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+12K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+12K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+12K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+12K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+13K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+13K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+14K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+14K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+14K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+15K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+15K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+16K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+17K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+18K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601