510(k) Report

Devices descending from K921111

218 later devices reach S-Rom Zirconia Cermamic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+9K202730Quadra-PMedacta International S.A.20201—
+9K192827Quadra-PMedacta International S.A.20206—
+9K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+10K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+10K220405Amis K LongMedacta International S.A.20220—
+10K210062Mectaplug PE IIMedacta International S.A.20210—
+10K203041SMS Cementless StemMedacta International S.A.20201—