510(k) Report

Devices descending from K043536

342 later devices reach Navitrack System - S&N Image Free Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252246Leforte MMF SystemJeil Medical Corporation20260—
+10K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+10K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+10K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+10K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+10K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+10K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+10K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+10K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+10K192592Axis Plating SystemExtremity Medical, LLC20190—
+10K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+10K191223NAVIOBlue Belt Technologies, Inc.201915—
+11K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+11K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+11K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+11K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+11K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+11K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+11K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+12K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+12K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+12K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+13K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+13K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+13K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+14K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+14K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+14K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+15K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+16K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601