510(k) Report

Devices descending from K121936

22 later devices reach Naviopfs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140596NAVIOBlue Belt Technologies, Inc.201421—
+2K143668NavioBlue Belt Technologies, Inc.201520—
+3K152574NavioBlue Belt Technologies, Inc.201519—
+4K160537NavioBlue Belt Technologies, Inc.201618—
+5K170360NAVIOBlue Belt Technologies, Inc.201717—
+6K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+7K191223NAVIOBlue Belt Technologies, Inc.201915—
+8K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+8K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+9K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+10K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+11K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+11K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+12K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+12K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+12K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+13K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+13K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+14K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+14K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+14K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+14K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—