510(k) Report

Devices descending from K945115

537 later devices reach Mallory-Head Modular Calcar Repacement Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+11K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+11K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+11K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+11K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+11K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+11K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+11K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+12K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+12K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+12K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+12K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+12K251166Mfinity Femoral SystemMedacta International S.A.20250—
+12K251052Trivicta® Hip StemOrtho Development Corp.20250—
+12K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+12K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+12K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+12K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+12K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+12K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+12K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+12K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+12K211703Insignia Hip StemStryker Orthopaedics20217—
+12K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+12K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+12K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+12K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+12K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+12K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+13K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+13K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+13K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+13K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+14K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+15K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+15K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+15K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—