510(k) Report

Devices descending from K180271

16 later devices reach NAVIO™ Surgical System (NAVIO system) through their predicates, nearest generation first.

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