510(k) Report

Devices descending from K933787

121 later devices reach Porocoat Porous Coating/Aml Proximally-Coated Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+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—
+8K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K201315PERFORM Humeral System – StemTornier, Inc.2020111
+9K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+9K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+9K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+9K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501