510(k) Report

Devices descending from K161742

53 later devices reach Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+1K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+1K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+1K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+1K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+1K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+1K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+1K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+1K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+1K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+1K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+1K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+1K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+1K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+1K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+1K193175Lateralized GlenosphereMedacta Inernational SA20201—
+1K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+1K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+1K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+1K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+1K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+2K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+2K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+2K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+2K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+2K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+2K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+2K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+2K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+2K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+2K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+2K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+2K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+2K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+3K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+3K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+3K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+3K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+3K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+4K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—