510(k) Report

Devices descending from K111433

39 later devices reach Depuy Sttune (TM) PS Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+1K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+1K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+1K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+1K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+1K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+1K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+1K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+2K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+2K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+2K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+2K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+3K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+3K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+3K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+3K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+3K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+4K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+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—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301