510(k) Report

Devices descending from K170360

17 later devices reach NAVIO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+2K191223NAVIOBlue Belt Technologies, Inc.201915—
+3K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+3K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+4K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+5K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+6K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+6K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+7K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—