510(k) Report

Devices descending from K921274

644 later devices reach Metallic Toatal Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+9K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+9K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+9K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+9K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+9K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+9K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+9K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+9K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+9K130634Corin Metafix Hip StemCorin USA20135—
+9K121563Corin Trifit TS HipCorin USA2012101
+9K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+10K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+10K254003JARVIS Metaphyseal StemFH Industrie20260—
+10K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+10K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+10K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+10K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+10K243248Inhance Intact™Depuy Ireland UC20240—
+10K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+10K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+10K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+10K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+10K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+10K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+10K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+10K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+10K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+10K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+10K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+11K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+11K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+11K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+11K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+11K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+12K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+13K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301