510(k) Report

Devices descending from K960279

312 later devices reach Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+9K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+9K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301