510(k) Report

Devices descending from K172501

7 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—
+1K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+1K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+2K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K243162World LinerSignature Orthopaedics Pty, Ltd.20240—