510(k) Report

Devices descending from K961939

210 later devices reach S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K202730Quadra-PMedacta International S.A.20201—
+8K192827Quadra-PMedacta International S.A.20206—
+8K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K220405Amis K LongMedacta International S.A.20220—
+9K210062Mectaplug PE IIMedacta International S.A.20210—
+9K203041SMS Cementless StemMedacta International S.A.20201—