510(k) Report

Devices descending from K934412

377 later devices reach Coated ZT Proximal Sleeve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+7K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+7K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+7K192126AMIStem-P Short NeckMedacta International S.A.20191—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K181254Quadra PMedacta International S.A.20187—
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+7K121563Corin Trifit TS HipCorin USA2012101
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+8K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+8K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+8K202730Quadra-PMedacta International S.A.20201—
+8K201315PERFORM Humeral System – StemTornier, Inc.2020111
+8K192827Quadra-PMedacta International S.A.20206—
+8K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+8K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+8K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+8K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+8K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+8K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+8K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+9K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+9K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+9K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+9K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+9K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+9K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+9K210062Mectaplug PE IIMedacta International S.A.20210—
+9K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+10K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—