510(k) Report

Devices descending from K160537

18 later devices reach Navio through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170360NAVIOBlue Belt Technologies, Inc.201717—
+2K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+3K191223NAVIOBlue Belt Technologies, Inc.201915—
+4K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+4K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+5K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+6K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+10K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—