510(k) Report

Devices descending from K954935

326 later devices reach S-Rom Femoral Hip Stem - Size 14 X 8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+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—
+8K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+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—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+9K220405Amis K LongMedacta International S.A.20220—
+9K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+9K210062Mectaplug PE IIMedacta International S.A.20210—
+9K203041SMS Cementless StemMedacta International S.A.20201—
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—