510(k) Report

Devices descending from K191936

2 later devices reach iNSitu Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+1K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—