510(k) Report

Devices descending from K040267

163 later devices reach Triathlon Cruciate Retaining (CR) Total Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+4K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+5K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+5K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+5K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+6K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+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
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+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