Product Code: MBH FDA class 2 21 CFR 888.3565

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

Orthopedic

The semi-constrained uncemented porous coated polymer/metal/polymer patello/femorotibial knee prosthesis is an orthopedic implant used to resurface the knee joint in patients with degenerative joint disease, relying on porous coating for osseointegration without bone cement. It is classified as FDA Class II under 21 CFR 888.3565 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBH and it carries an implant flag reflecting its permanent surgical placement. Full GMP compliance is required.

View on FDA

510(k)s

143

FEI Numbers

219

Registration Numbers

219

Unique Applicants

Years Active

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Basic Information

Product Code: MBH
Device Class: FDA class 2
Regulation Number: 888.3565
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 143 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251840	Zimmer® Persona® Personalized Knee System	May 28, 2026	Substantially Equivalent	Zimmer, Inc.
K253189	Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)	Mar 09, 2026	Substantially Equivalent	Zimmer, Inc.
K253328	GMK 3D Metal Tibial Tray Extension	Feb 26, 2026	Substantially Equivalent	Medacta International S.A.
K253637	Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert	Feb 18, 2026	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K253239	Active-V Total Knee System; World Total Knee System	Dec 23, 2025	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K253161	Balanced Knee System TriMax Porous Femoral Components	Dec 19, 2025	Substantially Equivalent	Ortho Development Corp.
K252777	Freedom Metaphyseal Cone Implants (Metaphyseal Cones)	Oct 31, 2025	Substantially Equivalent	Maxx Orthopedics, Inc.
K252044	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	Oct 24, 2025	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K243656	U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella	Jul 31, 2025	Substantially Equivalent	United Orthopedic Corporation
K250980	Physica System (Physica CR Porous Femoral components)	May 22, 2025	Substantially Equivalent	Lima Corporate S.P.A.
K243768	iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System	Mar 27, 2025	Substantially Equivalent	Restor3D, Inc.
K241597	Freedom® Total Knee System - Porous Tibial Base Plate	Feb 13, 2025	Substantially Equivalent	Maxx Orthopedics, Inc.
K243293	Zimmer® Persona® Personalized Knee System	Dec 20, 2024	Substantially Equivalent	Zimmer Biomet
K243615	Physica Porous Femoral Components	Dec 18, 2024	Substantially Equivalent	Lima Corporate S.P.A.
K242543	Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)	Nov 22, 2024	Substantially Equivalent	Zimmer, Inc.
K242412	Agility Symmetric Total Knee System	Nov 06, 2024	Substantially Equivalent	Medisurge, LLC
K243247	Persona the Personalized Knee System	Oct 29, 2024	Substantially Equivalent	Zimmer, Inc.
K240393	Exactech® TRULIANT® Knee System	Oct 03, 2024	Substantially Equivalent	Exactech, Inc.
K240938	The Optimotion Blue Plus Knee System	Jun 27, 2024	Substantially Equivalent	Optimotion Implants, LLC
K240678	ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology	Jun 18, 2024	Substantially Equivalent	Depuy Ireland UC
K240299	Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)	Apr 26, 2024	Substantially Equivalent	Zimmer, Inc.
K233507	EVOLUTION® Tibial Cones	Jan 18, 2024	Substantially Equivalent	Microport Orthopedics, Inc.
K232303	ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology	Dec 11, 2023	Substantially Equivalent	Depuy Ireland UC
K232426	Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts	Sep 08, 2023	Substantially Equivalent	Conformis, Inc.
K223316	Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System	Jul 21, 2023	Substantially Equivalent	Conformis, Inc.
K230295	ATTUNE® Revision Cones	Mar 10, 2023	Substantially Equivalent	Depuy Ireland UC
K221705	U2 Total Knee System-PF+	Feb 28, 2023	Substantially Equivalent	United Orthopedic Corporation
K223548	GMK Sphere & GMK SpheriKA Cementless	Jan 20, 2023	Substantially Equivalent	Medacta International S.A.
K222566	Zimmer Persona Personalized Knee System	Oct 17, 2022	Substantially Equivalent	Zimmer, Inc.
K212746	ATTUNE Revision Cones	Oct 17, 2022	Substantially Equivalent	Depuy Ireland UC
K221850	GMK 3D Metal Tibial Tray	Aug 23, 2022	Substantially Equivalent	Medacta International S.A.
K220049	Optimotion Implants Porous Metal-Backed Patella	Mar 14, 2022	Substantially Equivalent	Optimotion Implants, LLC
K212941	Porous Patella	Jan 20, 2022	Substantially Equivalent	Encore Medical, L.P. Dba Djo Surgical
K213781	ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP	Jan 18, 2022	Substantially Equivalent	Depuy Ireland UC
K213817	MPO Knee Instruments; MPO PROPHECY Knee Instruments	Jan 05, 2022	Substantially Equivalent	Microport Orthopedics, Inc.
K211221	Porous Patella and Porous Tibia Baseplate	Oct 01, 2021	Substantially Equivalent	Smith & Nephew, Inc.
K203779	Symmetric Total Knee System	Jun 10, 2021	Substantially Equivalent	Signal Medical Corporation
K211246	LEGION CR Porous Plus HA Femoral Components	May 24, 2021	Substantially Equivalent	Smith & Nephew, Inc.
K210554	Physica system	Apr 06, 2021	Substantially Equivalent	Lima Corporate S.P.A.
K210308	EMPOWR Porous Femur with HAnano SurfaceTM	Mar 30, 2021	Substantially Equivalent	Encore Medical L.P.
K210566	LEGION Porous CR Narrow Femoral Components	Mar 25, 2021	Substantially Equivalent	Smith & Nephew, Inc.
K201084	Physica system	Dec 14, 2020	Substantially Equivalent	Lima Corporate S.P.A.
K202194	ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology	Nov 25, 2020	Substantially Equivalent	Depuy Ireland UC
K193312	UNIKO PointCloud Knee Instruments	Aug 12, 2020	Substantially Equivalent	Unik Orthopedics, Inc.
K201364	LINK TrabecuLink Femoral Cones	Jul 17, 2020	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K200782	Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite	May 13, 2020	Substantially Equivalent	Howmedica Osteonics Corp.
K191084	The Optimotion Blue Total Knee System	Apr 07, 2020	Substantially Equivalent	Optimotion Implants, LLC
K200113	LINK TrabecuLink Tibial Cones	Mar 18, 2020	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K190991	Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment	Aug 15, 2019	Substantially Equivalent	Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
K182346	TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws	Nov 26, 2018	Substantially Equivalent	Exactech, Inc.
K181794	Truliant Porous Femoral Components	Sep 28, 2018	Substantially Equivalent	Exactech, Inc.
K172524	Zimmer Persona Personalized Knee System	May 17, 2018	Substantially Equivalent	Zimmer, Inc.
K180317	EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System	May 04, 2018	Substantially Equivalent	Microport Orthopedics, Inc.
K173849	Triathlon Total Knee System	Feb 02, 2018	Substantially Equivalent	Stryker Orthopaedics
K173417	Zimmer Persona Personalized Knee System	Jan 30, 2018	Substantially Equivalent	Zimmer, Inc.
K172634	Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components	Nov 16, 2017	Substantially Equivalent	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
K171365	Arthrex Knee Systems	Nov 07, 2017	Substantially Equivalent	Arthrex, Inc.
K171991	EMPOWR Porous Knee System	Oct 04, 2017	Substantially Equivalent	Encore Medical L.P.
K170288	BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell	Jun 15, 2017	Substantially Equivalent	Microport Orthopedics, Inc.
K162256	Klassic Femur, Porous, Klassic Tibial Baseplate, Porous	Oct 27, 2016	Substantially Equivalent	Total Joint Orthopedics, Inc.
K153657	Vanguard XP Knee System	May 10, 2016	Substantially Equivalent	Biomet, Inc.
K153776	Optetrak One Logic Femoral Components	Mar 10, 2016	Substantially Equivalent	Exactech, Inc.
K153586	Arthrex iBalance TKA System	Feb 19, 2016	Substantially Equivalent	Arthrex, Inc.
K152298	EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base	Nov 16, 2015	Substantially Equivalent	Microport Orthopedics, Inc.
K152252	Arthrex iBalance TKA System	Nov 16, 2015	Substantially Equivalent	Arthrex, Inc.
K150832	U2 Femoral Component, CR, Porous Coated, Additional Sizes	Sep 25, 2015	Substantially Equivalent	United Orthopedic Corporation
K150680	Freedom Cementless Femoral Component	Jun 26, 2015	Substantially Equivalent	Maxx Orthopedics, Inc.
K150090	Zimmer Persona Personalized Knee System	May 20, 2015	Substantially Equivalent	Zimmer, Inc.
K140881	DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS	Feb 13, 2015	Substantially Equivalent	Depuy(Ireland)
K143366	ADVANCE Porous Coated Spiked Tibial Base	Jan 21, 2015	Substantially Equivalent	Microport Orthopedics, Inc.
K143393	Triathlon Tritanium Cone Augments	Jan 13, 2015	Substantially Equivalent	Stryker Orthopaedics
K141407	VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL	Oct 27, 2014	Substantially Equivalent	Biomet, Inc.
K141840	TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH	Sep 03, 2014	Substantially Equivalent	Zimmer, Inc.
K141635	ARTHREX IBALANCE TKA SYSTEM	Sep 03, 2014	Substantially Equivalent	Arthrex, Inc.
K140735	EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS	Aug 29, 2014	Substantially Equivalent	Microport Orthopedics, Inc.
K141056	TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS	Aug 05, 2014	Substantially Equivalent	Stryker Orthopaedics
K140883	VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT	Jul 30, 2014	Substantially Equivalent	Biomet, Inc.
K140302	OPTETRAK LOGIC POROUS FEMORAL COMPONENTS	Jul 30, 2014	Substantially Equivalent	Exactech, Inc.
K140075	U2 FEMORAL COMPONENT, CR, POROUS COATED	Jun 13, 2014	Substantially Equivalent	United Orthopedic Corp.
K140257	SIGNATURE PLANNER, SIGNATURE GUIDES	Apr 02, 2014	Substantially Equivalent	Materialise NV
K132873	VANGUARD XP KNEE SYSTEM	Dec 11, 2013	Substantially Equivalent	Biomet, Inc.
K132624	TRIATHLON TRITANIUM METAL-BACKED PATELLA	Nov 26, 2013	Substantially Equivalent	Stryker Orthopaedics
K123486	TRIATHLON TRITANIUM TIBIAL BASEPLATE	May 03, 2013	Substantially Equivalent	Stryker
K122218	ADVANCE TOTAL KNEE SYSTEM-PATELLA	Mar 21, 2013	Substantially Equivalent	Wrightmedicaltechnologyinc
K122160	VANGUARD XP KNEE SYSTEM	Mar 20, 2013	Substantially Equivalent	Biomet Manufacturing Corp
K123459	ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM	Feb 22, 2013	Substantially Equivalent	Zimmer, Inc.
K122745	ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM	Dec 05, 2012	Substantially Equivalent	Zimmer, Inc.
K121771	ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM	Nov 07, 2012	Substantially Equivalent	Zimmer, Inc.
K122053	SHAPEMATCH CUTTING GUIDE	Oct 24, 2012	Substantially Equivalent	Stryker Corp.
K121393	SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION	Aug 07, 2012	Substantially Equivalent	Smith & Nephew, Inc.
K120990	NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL	Jun 29, 2012	Substantially Equivalent	Zimmer Trabecular Metal Technology
K103598	PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES	Oct 17, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K110950	CONSENSUS KNEE SYSTEM	Jun 27, 2011	Substantially Equivalent	Consensus Orthopedics, Inc.
K110533	STRYKER PATIENT SPECIFIC CUTTING GUIDE	May 19, 2011	Substantially Equivalent	Stryker Corp.
K103517	TRABECULAR METAL FEMORAL CONE AUGMENTS	Feb 15, 2011	Substantially Equivalent	Zimmer Trabecular Metal Technology, Inc.
K102927	CONSENSUS KNEE SYSTEM	Jan 26, 2011	Substantially Equivalent	Consensus Orthopedics, Inc.
K102896	TRABECULAR METAL TIBIAL CONE AUGMENTS	Dec 13, 2010	Substantially Equivalent	Zimmer Trabecular Metal Technology
K093405	PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES	May 25, 2010	Substantially Equivalent	Wrightmedicaltechnologyinc
K100897	LEGION POROUS + HA TIBIAL BASEPLATES	May 13, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K093533	ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0	Feb 17, 2010	Substantially Equivalent	Materialise NV
K091543	LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS	Dec 21, 2009	Substantially Equivalent	Smith & Nephew, Inc.
K083782	REGENEREX PATELLA COMPONENTS	Apr 03, 2009	Substantially Equivalent	Biomet Manufacturing Corp
K081479	ADVANCE A-CLASS TIBIAL INSERT	Feb 20, 2009	Substantially Equivalent	Wrightmedicaltechnologyinc
K080842	APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]	May 23, 2008	Substantially Equivalent	Omni Life Science, Inc.
K080361	REGENEREX TIBIAL COMPONENTS	Apr 21, 2008	Substantially Equivalent	Biomet, Inc.
K072575	TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE	Jan 07, 2008	Substantially Equivalent	Stryker Orthopaedics
K073325	LEGION POROUS PRIMARY	Dec 20, 2007	Substantially Equivalent	Smith & Nephew, Inc.
K072619	NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS	Nov 21, 2007	Substantially Equivalent	Zimmer, Inc.
K072160	NEXGEN TRABECULAR METAL TIBIAL TRAY	Sep 05, 2007	Substantially Equivalent	Zimmer, Inc.
K071790	GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM	Aug 17, 2007	Substantially Equivalent	Smith & Nephew, Inc.
K071417	DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES	Aug 02, 2007	Substantially Equivalent	DePuy Orthopaedics, Inc.
K071107	GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON	Jul 06, 2007	Substantially Equivalent	Zimmer, Inc.
K070883	DURACON X3 CS TIBIAL INSERT	May 11, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K063128	ADVANCE SPIKED POROUS TIBIAL BASE	Mar 21, 2007	Substantially Equivalent	Wrightmedicaltechnologyinc
K070214	GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM	Mar 16, 2007	Substantially Equivalent	Zimmer, Inc.
K063731	ADVANCE STATURE FEMORAL COMPONENT	Mar 02, 2007	Substantially Equivalent	Wrightmedicaltechnologyinc
K062654	DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS	Sep 29, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K061433	VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE	Aug 21, 2006	Substantially Equivalent	Biomet Manufacturing, Inc.
K061223	ADVANCE TOTAL KNEE SYSTEM	Aug 18, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K053505	REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS	Aug 14, 2006	Substantially Equivalent	Biomet Manufacturing, Inc.
K061521	TRIATHLON METAL BACKED PATELLA	Aug 11, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K060303	VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS	Mar 30, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K051510	SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM	Mar 22, 2006	Substantially Equivalent	Signal Medical Corp.
K053340	TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS	Feb 27, 2006	Substantially Equivalent	Zimmer Trabecular
K051380	TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM	Aug 30, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K050222	VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS	Aug 16, 2005	Substantially Equivalent	Biomet, Inc.
K043083	ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL	Apr 18, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K043374	DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING	Feb 16, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K040487	TRABECULAR METAL KNEE SYSTEM AUGMENTS	Dec 21, 2004	Substantially Equivalent	Implex Corp.
K041100	NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS	Oct 29, 2004	Substantially Equivalent	Zimmer, Inc.
K041872	ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS	Sep 08, 2004	Substantially Equivalent	Biomet Manufacturing Corp
K032905	3DKNEE POROUS COATED FEMORAL COMPONENT	Jul 06, 2004	Substantially Equivalent	Encore Orthopedics, Inc.
K033489	AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN	Jun 02, 2004	Substantially Equivalent	Biomet, Inc.
K033971	SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING	May 28, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K033972	SCORPIO TOTAL KNEE SYSTEM	Apr 12, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K032108	SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)	Jan 15, 2004	Substantially Equivalent	Aesculap, Inc.
K032683	GENESIS II POROUS PLUS HA KNEE SYSTEM	Oct 15, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K031061	NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS	Oct 09, 2003	Substantially Equivalent	Zimmer, Inc.
K032163	DURACON TOTAL KNEE SYSTEM	Sep 12, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K032418	DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING	Sep 11, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K031462	THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS	Aug 06, 2003	Substantially Equivalent	Implex Corp.
K030612	GENESIS II TOTAL KNEE SYSTEM	May 27, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K030623	SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM	May 22, 2003	Substantially Equivalent	Smith & Nephew, Inc.