510(k) Report

Devices descending from K920524

140 later devices reach Osteonics 7000 Series Total Knee Bone Augmentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193559NextAR TKA PlatformMedacta Inernational SA202012—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K143453Mpact Double Mobility SystemMedacta International20151—
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+7K131458Mpact DM Liner ConverterMedacta International20133—
+7K122911Versafitcup CC Trio ExtensionMedacta International20121—
+7K122641Mpact ExtensionMedacta International201214—
+7K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+7K111145Endo HeadMedacta International20110—
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+8K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+8K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+8K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+8K211891DM Converter - TiN coatedMedacta International S.A.20220—
+8K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+8K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+8K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K202152NextAR TKA PlatformMedacta International S.A.202011—
+9K250477NextAR (TM) SpineMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+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—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+10K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—