Orthopedic

MBH · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Orthopedic · 21 CFR 888.3565 · Class 2

Overview

Product CodeMBH
Device NameProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation21 CFR 888.3565
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Classification Rationale

Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Cleared Devices (142)

RecordDevice NameApplicantDecision DateDecision
K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.Mar 9, 2026SESE
K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.Feb 26, 2026SESE
K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsFeb 18, 2026SESE
K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.Dec 23, 2025SESE
K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.Dec 19, 2025SESE
K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.Oct 31, 2025SESE
K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker OrthopaedicsOct 24, 2025SESE
K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic CorporationJul 31, 2025SESE
K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.May 22, 2025SESE
K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.Mar 27, 2025SESE
K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.Feb 13, 2025SESE
K243293Zimmer® Persona® Personalized Knee SystemZimmer BiometDec 20, 2024SESE
K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.Dec 18, 2024SESE
K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.Nov 22, 2024SESE
K242412Agility Symmetric™ Total Knee SystemMedisurge, LLCNov 6, 2024SESE
K243247Persona the Personalized Knee SystemZimmer, Inc.Oct 29, 2024SESE
K240393Exactech® TRULIANT® Knee SystemExactech, Inc.Oct 3, 2024SESE
K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLCJun 27, 2024SESE
K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP TechnologyDepuy Ireland UCJun 18, 2024SESE
K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.Apr 26, 2024SESE
K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.Jan 18, 2024SESE
K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyDepuy Ireland UCDec 11, 2023SESE
K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsConformis, Inc.Sep 8, 2023SESE
K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemConformis, Inc.Jul 21, 2023SESE
K230295ATTUNE® Revision ConesDepuy Ireland UCMar 10, 2023SESE
K221705U2 Total Knee System-PF+United Orthopedic CorporationFeb 28, 2023SESE
K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.Jan 20, 2023SESE
K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.Oct 17, 2022SESE
K212746ATTUNE Revision ConesDepuy Ireland UCOct 17, 2022SESE
K221850GMK 3D Metal Tibial TrayMedacta International S.A.Aug 23, 2022SESE
K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLCMar 14, 2022SESE
K212941Porous PatellaEncore Medical, L.P. Dba Djo SurgicalJan 20, 2022SESE
K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UCJan 18, 2022SESE
K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.Jan 5, 2022SESE
K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.Oct 1, 2021SESE
K203779Symmetric Total Knee SystemSignal Medical CorporationJun 10, 2021SESE
K211246LEGION CR Porous Plus HA Femoral ComponentsSmith & Nephew, Inc.May 24, 2021SESE
K210554Physica systemLima Corporate S.P.A.Apr 6, 2021SESE
K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.Mar 30, 2021SESE
K210566LEGION Porous CR Narrow Femoral ComponentsSmith & Nephew, Inc.Mar 25, 2021SESE
K201084Physica systemLima Corporate S.P.A.Dec 14, 2020SESE
K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyDepuy Ireland UCNov 25, 2020SESE
K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.Aug 12, 2020SESE
K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KGJul 17, 2020SESE
K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-ApatiteHowmedica Osteonics Corp.May 13, 2020SESE
K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLCApr 7, 2020SESE
K200113LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KGMar 18, 2020SESE
K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)Aug 15, 2019SESE
K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.Nov 26, 2018SESE
K181794Truliant Porous Femoral ComponentsExactech, Inc.Sep 28, 2018SESE
K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.May 17, 2018SESE
K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK SystemMicroport Orthopedics, Inc.May 4, 2018SESE
K173849Triathlon Total Knee SystemStryker OrthopaedicsFeb 2, 2018SESE
K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.Jan 30, 2018SESE
K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsNov 16, 2017SESE
K171365Arthrex Knee SystemsArthrex, Inc.Nov 7, 2017SESE
K171991EMPOWR Porous Knee SystemEncore Medical L.P.Oct 4, 2017SESE
K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular ShellMicroport Orthopedics, Inc.Jun 15, 2017SESE
K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.Oct 27, 2016SESE
K153657Vanguard XP Knee SystemBiomet, Inc.May 10, 2016SESE
K153776Optetrak One Logic Femoral ComponentsExactech, Inc.Mar 10, 2016SESE
K153586Arthrex iBalance TKA SystemArthrex, Inc.Feb 19, 2016SESE
K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial BaseMicroport Orthopedics, Inc.Nov 16, 2015SESE
K152252Arthrex iBalance TKA SystemArthrex, Inc.Nov 16, 2015SESE
K150832U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic CorporationSep 25, 2015SESE
K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.Jun 26, 2015SESE
K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.May 20, 2015SESE
K140881DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETSDepuy(Ireland)Feb 13, 2015SESE
K143366ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc.Jan 21, 2015SESE
K143393Triathlon Tritanium Cone AugmentsStryker OrthopaedicsJan 13, 2015SESE
K141407VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIALBiomet, Inc.Oct 27, 2014SESE
K141840TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACHZimmer, Inc.Sep 3, 2014SESE
K141635ARTHREX IBALANCE TKA SYSTEMArthrex, Inc.Sep 3, 2014SESE
K140735EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTSMicroport Orthopedics, Inc.Aug 29, 2014SESE
K141056TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSStryker OrthopaedicsAug 5, 2014SESE
K140883VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENTBiomet, Inc.Jul 30, 2014SESE
K140302OPTETRAK LOGIC POROUS FEMORAL COMPONENTSExactech, Inc.Jul 30, 2014SESE
K140075U2 FEMORAL COMPONENT, CR, POROUS COATEDUnited Orthopedic Corp.Jun 13, 2014SESE
K140257SIGNATURE PLANNER, SIGNATURE GUIDESMaterialise NVApr 2, 2014SESE
K132873VANGUARD XP KNEE SYSTEMBiomet, Inc.Dec 11, 2013SESE
K132624TRIATHLON TRITANIUM METAL-BACKED PATELLAStryker OrthopaedicsNov 26, 2013SESE
K123486TRIATHLON TRITANIUM TIBIAL BASEPLATEStrykerMay 3, 2013SESE
K122218ADVANCE TOTAL KNEE SYSTEM-PATELLAWrightmedicaltechnologyincMar 21, 2013SESE
K122160VANGUARD XP KNEE SYSTEMBiomet Manufacturing CorpMar 20, 2013SESE
K123459ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc.Feb 22, 2013SESE
K122745ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.Dec 5, 2012SESE
K121771ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.Nov 7, 2012SESE
K122053SHAPEMATCH CUTTING GUIDEStryker Corp.Oct 24, 2012SESE
K121393SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.Aug 7, 2012SESE
K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIALZimmer Trabecular Metal TechnologyJun 29, 2012SESE
K103598PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyincOct 17, 2011SESE
K110950CONSENSUS KNEE SYSTEMConsensus Orthopedics, Inc.Jun 27, 2011SESE
K110533STRYKER PATIENT SPECIFIC CUTTING GUIDEStryker Corp.May 19, 2011SESE
K103517TRABECULAR METAL FEMORAL CONE AUGMENTSZimmer Trabecular Metal Technology, Inc.Feb 15, 2011SESE
K102927CONSENSUS KNEE SYSTEMConsensus Orthopedics, Inc.Jan 26, 2011SESE
K102896TRABECULAR METAL TIBIAL CONE AUGMENTSZimmer Trabecular Metal TechnologyDec 13, 2010SESE
K093405PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyincMay 25, 2010SESE
K100897LEGION POROUS + HA TIBIAL BASEPLATESSmith & Nephew, Inc.May 13, 2010SESE
K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0Materialise NVFeb 17, 2010SESE
K091543LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTSSmith & Nephew, Inc.Dec 21, 2009SESE
K083782REGENEREX PATELLA COMPONENTSBiomet Manufacturing CorpApr 3, 2009SESE
K081479ADVANCE A-CLASS TIBIAL INSERTWrightmedicaltechnologyincFeb 20, 2009SESE
K080842APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]Omni Life Science, Inc.May 23, 2008SESE
K080361REGENEREX TIBIAL COMPONENTSBiomet, Inc.Apr 21, 2008SESE
K072575TRIATHLON SCREW-FIXATION TIBIAL BASEPLATEStryker OrthopaedicsJan 7, 2008SESE
K073325LEGION POROUS PRIMARYSmith & Nephew, Inc.Dec 20, 2007SESE
K072619NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTSZimmer, Inc.Nov 21, 2007SESE
K072160NEXGEN TRABECULAR METAL TIBIAL TRAYZimmer, Inc.Sep 5, 2007SESE
K071790GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEMSmith & Nephew, Inc.Aug 17, 2007SESE
K071417DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVESDePuy Orthopaedics, Inc.Aug 2, 2007SESE
K071107GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPONZimmer, Inc.Jul 6, 2007SESE
K070883DURACON X3 CS TIBIAL INSERTHowmedica Osteonics Corp.May 11, 2007SESE
K063128ADVANCE SPIKED POROUS TIBIAL BASEWrightmedicaltechnologyincMar 21, 2007SESE
K070214GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEMZimmer, Inc.Mar 16, 2007SESE
K063731ADVANCE STATURE FEMORAL COMPONENTWrightmedicaltechnologyincMar 2, 2007SESE
K062654DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTSDePuy Orthopaedics, Inc.Sep 29, 2006SESE
K061433VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVEBiomet Manufacturing, Inc.Aug 21, 2006SESE
K061223ADVANCE TOTAL KNEE SYSTEMWrightmedicaltechnologyincAug 18, 2006SESE
K053505REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTSBiomet Manufacturing, Inc.Aug 14, 2006SESE
K061521TRIATHLON METAL BACKED PATELLAHowmedica Osteonics Corp.Aug 11, 2006SESE
K060303VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTSBiomet Manufacturing CorpMar 30, 2006SESE
K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMSignal Medical Corp.Mar 22, 2006SESE
K053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTSZimmer TrabecularFeb 27, 2006SESE
K051380TRIATHLON PRESS-FIT TOTAL KNEE SYSTEMHowmedica Osteonics Corp.Aug 30, 2005SESE
K050222VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGSBiomet, Inc.Aug 16, 2005SESE
K043083ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEELWrightmedicaltechnologyincApr 18, 2005SESE
K043374DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATINGHowmedica Osteonics Corp.Feb 16, 2005SESE
K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSImplex Corp.Dec 21, 2004SESE
K041100NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTSZimmer, Inc.Oct 29, 2004SESE
K041872ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGSBiomet Manufacturing CorpSep 8, 2004SESE
K0329053DKNEE POROUS COATED FEMORAL COMPONENTEncore Orthopedics, Inc.Jul 6, 2004SESE
K033489AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWNBiomet, Inc.Jun 2, 2004SESE
K033971SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATINGHowmedica Osteonics Corp.May 28, 2004SESE
K033972SCORPIO TOTAL KNEE SYSTEMHowmedica Osteonics Corp.Apr 12, 2004SESE
K032108SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)Aesculap, Inc.Jan 15, 2004SESE
K032683GENESIS II POROUS PLUS HA KNEE SYSTEMSmith & Nephew, Inc.Oct 15, 2003SESE
K031061NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTSZimmer, Inc.Oct 9, 2003SESE
K032163DURACON TOTAL KNEE SYSTEMHowmedica Osteonics Corp.Sep 12, 2003SESE
K032418DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATINGHowmedica Osteonics Corp.Sep 11, 2003SESE
K031462THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTSImplex Corp.Aug 6, 2003SESE
K030612GENESIS II TOTAL KNEE SYSTEMSmith & Nephew, Inc.May 27, 2003SESE
K030623SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEMSmith & Nephew, Inc.May 22, 2003SESE

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