510(k) Report

Devices descending from K962152

283 later devices reach Osteonics Scorpio Posteriorly Stabilized Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+6K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+6K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+6K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+6K132879Mpact ExtensionMedacta International201411—
+6K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+6K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+6K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K111145Endo HeadMedacta International20110—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+7K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+7K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K202152NextAR TKA PlatformMedacta International S.A.202011—
+7K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+7K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+7K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+8K250477NextAR (TM) SpineMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+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
+8K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+8K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+8K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+8K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+8K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+8K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+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—
+9K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301