Product Code: HSX FDA class 2 21 CFR 888.3520

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Orthopedic

A non-constrained, cemented, metal/polymer femorotibial knee prosthesis is a total knee replacement implant that allows unconstrained motion at the joint interface and is fixed to bone using cement, used to treat severe knee arthritis or joint damage. It is classified as an FDA Class 2 device under 21 CFR 888.3520, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSX falls under the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

114

FEI Numbers

159

Registration Numbers

159

Unique Applicants

Years Active

Research product code HSX in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HSX
Device Class: FDA class 2
Regulation Number: 888.3520
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 114 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260796	Tahoe Unicondylar Knee System with TiNbN Overcoat	Apr 02, 2026	Substantially Equivalent	Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
K251771	Cambridge Partial Knee	Dec 16, 2025	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K251834	Persona Partial Knee	Aug 15, 2025	Substantially Equivalent	Zimmer Biomet
K251618	MOTO Partial Knee System Extension	Jul 24, 2025	Substantially Equivalent	Medacta International S.A.
K251453	Arthrex iBalance Partial Knee System	Jul 01, 2025	Substantially Equivalent	Arthrex, Inc.
K241260	ACTIFY Unicondylar Knee System	Dec 06, 2024	Substantially Equivalent	Globus Medical, Inc.
K242711	JOURNEY II Unicompartmental Knee System (JOURNEY II UK)	Oct 30, 2024	Substantially Equivalent	Smith & Nephew, Inc.
K242746	OvertureTi Knee Resurfacing SystemTM	Oct 07, 2024	Substantially Equivalent	Overture Orthopaedics
K232114	TRIBRID® Unicompartmental Knee System	Apr 04, 2024	Substantially Equivalent	Kyocera Medical Technologies, Inc.
K221292	Uni Knee Resurfacing System	Mar 10, 2023	Substantially Equivalent	Overture Resurfacing, Inc.
K212870	TLC Unicompartmental Knee System	Jun 16, 2022	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K220930	Restoris Multi-Compartmental Knee System	Jun 02, 2022	Substantially Equivalent	Mako Surgical Corp.
K211471	Balanced Knee System Uni	Dec 16, 2021	Substantially Equivalent	Ortho Development Corporation
K213071	MOTOTM Partial Knee & MOTO PFJ Systems Extension	Nov 16, 2021	Substantially Equivalent	Medacta International S.A.
K212307	BC Reflex Uni Knee System	Oct 12, 2021	Substantially Equivalent	Bodycad Laboratories, Inc.
K211512	VISIONAIRE UK Patient Matched Cutting Guides	Sep 16, 2021	Substantially Equivalent	Smith & Nephew, Inc.
K211895	BC Reflex Uni Knee System	Aug 20, 2021	Substantially Equivalent	Bodycad Laboratories, Inc.
K203697	BC Reflex Uni Knee System	Mar 12, 2021	Substantially Equivalent	Bodycad Laboratories, Inc.
K203341	ACS LD Uni FB Knee System	Jan 08, 2021	Substantially Equivalent	Implantcast GmbH
K203099	Triathlon PKR System	Oct 27, 2020	Substantially Equivalent	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
K202207	Materialise PKA Guide System	Oct 02, 2020	Substantially Equivalent	Materialise NV
K200433	iBalance UKA Tibial Tray Implant	Mar 17, 2020	Substantially Equivalent	Arthrex, Inc.
K200151	Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill	Mar 17, 2020	Substantially Equivalent	Zimmer, Inc.
K191996	BC Reflex Uni Knee System	Dec 05, 2019	Substantially Equivalent	Bodycad Laboratories, Inc.
K191150	Bodycad Unicompartmental Knee System	Oct 08, 2019	Substantially Equivalent	Bodycad Laboratories, Inc.
K191211	JOURNEY II Unicompartmental Knee System	Jul 25, 2019	Substantially Equivalent	Smith & Nephew, Inc.
K191325	EMPOWR Partial Knee	Jul 16, 2019	Substantially Equivalent	Encore Medical L.P.
K190085	Journey II Unicompartmental Knee System	Feb 11, 2019	Substantially Equivalent	Smith & Nephew, Inc.
K183029	MOTO Partial Knee System	Jan 30, 2019	Substantially Equivalent	Medacta International S.A.
K181302	Bodycad Unicompartmental Knee System	Jan 17, 2019	Substantially Equivalent	Bodycad Laboratories, Inc.
K173970	Materialise PKA Guide System	Jul 06, 2018	Substantially Equivalent	Materialise NV
K180612	Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts	Jun 07, 2018	Substantially Equivalent	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
K172650	Materialise PKA Guide System	Nov 20, 2017	Substantially Equivalent	Materialise NV
K170344	Tahoe Uni Knee System	Oct 05, 2017	Substantially Equivalent	Consensus Orthopedics, Inc.
K161741	GMK UNI	Apr 14, 2017	Substantially Equivalent	Medacta International S.A.
K163700	Bodycad Unicompartmental Knee System	Mar 29, 2017	Substantially Equivalent	Bodycad Laboratories, Inc.
K162084	MOTO Partial Knee System	Jan 03, 2017	Substantially Equivalent	Medacta International S.A.
K161060	Arthrex iBalance UKA System Vitamin E Tibial Bearing	Dec 15, 2016	Substantially Equivalent	Arthrex, Inc.
K161592	Persona Partial Knee System	Nov 03, 2016	Substantially Equivalent	Biomet, Inc.
K160738	ZUK Select Knee System	Jun 15, 2016	Substantially Equivalent	Smith & Nephew, Inc.
K152315	JOURNEY II Uni Tibial Base and Insert	Oct 28, 2015	Substantially Equivalent	Smith & Nephew, Inc.
K132640	IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM	Dec 05, 2013	Substantially Equivalent	Conformis, Inc.
K123380	STRIDE UNICONDYLAR KNEE	May 31, 2013	Substantially Equivalent	Blue Belt Technologies, Inc.
K122529	ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE	Nov 16, 2012	Substantially Equivalent	Zimmer, Inc.
K121974	CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM	Sep 06, 2012	Substantially Equivalent	Conformis, Inc.
K120262	HLS UNI EVOLUTION & U-KNEETEC	Jul 25, 2012	Substantially Equivalent	Tornier, Inc.
K112301	ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER	Jan 06, 2012	Substantially Equivalent	Materialise NV
K113038	SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS	Jan 05, 2012	Substantially Equivalent	Smith & Nephew, Inc.
K111916	CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM	Sep 29, 2011	Substantially Equivalent	Conformis, Inc.
K102069	JOURNEY UNICONDYLAR TIBIAL BASEPLATES	Oct 05, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K101206	TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM	Jul 23, 2010	Substantially Equivalent	Alexandria Research Technologies, LLC
K100197	GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS	Feb 19, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K092441	MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM	Sep 09, 2009	Substantially Equivalent	Conformis, Inc.
K090024	TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM	May 04, 2009	Substantially Equivalent	Alexandria Research Technologies, LLC
K082172	MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM	Nov 28, 2008	Substantially Equivalent	Mako Surgical Corporation
K082081	MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III	Oct 15, 2008	Substantially Equivalent	Mako Surgical Corp.
K081351	MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT	Jul 24, 2008	Substantially Equivalent	Smith & Nephew, Inc.
K080368	MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II	Jun 20, 2008	Substantially Equivalent	Mako Surgical Corp.
K073175	JOURNEY UNICONDYLAR FEMORAL IMPLANT	Dec 20, 2007	Substantially Equivalent	Smith & Nephew, Inc.
K073248	MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM	Dec 12, 2007	Substantially Equivalent	Mako Surgical Corp.
K072586	CONFORMIS UNI-CONDYLAR KNEE SYSTEM	Nov 08, 2007	Substantially Equivalent	Conformis, Inc.
K072368	CONFORMIS METAL BACKED TIBIAL COMPONENT	Sep 20, 2007	Substantially Equivalent	Conformis, Inc.
K063432	CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)	Mar 16, 2007	Substantially Equivalent	Conformis, Inc.
K063782	ACCIN UNI-KNEE SYSTEM	Jan 19, 2007	Substantially Equivalent	Accin Corporation
K061779	COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE	Aug 04, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K061011	COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE	Jul 11, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K060670	ACCIN UNI-KNEE SYSTEM	Jun 02, 2006	Substantially Equivalent	Accin Corporation
K060017	MAKO SURGICAL UNICONDYLAR KNEE SYSTEM	Feb 23, 2006	Substantially Equivalent	Mako Surgical Corp.
K050373	UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS	Oct 11, 2005	Substantially Equivalent	Arthrosurface, Inc.
K043570	UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD	Mar 14, 2005	Substantially Equivalent	Conformis, Inc.
K033769	EIUS UNICOMPARTMENTAL KNEE SYSTEM	Feb 13, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K033363	ZIMMER UNICOMPARTMENTAL KNEE SYSTEM	Jan 16, 2004	Substantially Equivalent	Zimmer, Inc.
K032824	STELKAST UNICONDYLAR KNEE SYSTEM	Nov 13, 2003	Substantially Equivalent	Stelkast Company
K022211	HLS UNI EVOLUTION PROSTHESIS	May 22, 2003	Substantially Equivalent	Tornier
K011954	SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE	Sep 19, 2001	Substantially Equivalent	Sulzer Orthopedics, Inc.
K010685	MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)	Apr 02, 2001	Substantially Equivalent	Zimmer, Inc.
K992287	FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM	Nov 16, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K954186	SLED UNICOMPARTMENT KNEE SYSTEM	Jan 26, 1996	Substantially Equivalent	Link America, Inc.
K952068	ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES	Sep 19, 1995	Substantially Equivalent	Zimmer, Inc.
K942263	MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM	Jul 11, 1995	Substantially Equivalent for Some Indications	Zimmer, Inc.
K945613	DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT	Mar 06, 1995	Substantially Equivalent for Some Indications	Howmedica Corp.
K941606	PRESERVATION UNICOMPARTMENTAL KNEE	Oct 14, 1994	Substantially Equivalent	Depuy, Inc.
K931214	P.C.A. MODULAR KNEE SYSTEM	Feb 15, 1994	Substantially Equivalent	Howmedica Corp.
K926231	DURACON UNICOMPARTMENTAL KNEE SYSTEM	Mar 30, 1993	Substantially Equivalent	Howmedica Corp.
K922824	KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM	Sep 17, 1992	Substantially Equivalent	Joint Medical Products Corp.
K921232	KEANE UNI KNEE SYSTEM WITH POROCOAT	Jun 09, 1992	Substantially Equivalent	Depuy, Inc.
K915240	NATURAL-KNEE TIBIAL AND FEMORAL SPACERS	Jan 31, 1992	Substantially Equivalent	Intermedics Orthopedics
K912735	GENESIS UNICOMPARTMENTAL KNEE SYSTEM	Dec 27, 1991	Substantially Equivalent for Some Indications	Smith & Nephew Richards, Inc.
K914439	P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL	Oct 23, 1991	Substantially Equivalent	Johnson & Johnson Orthopaedics, Inc.
K910807	KEANE UNI KNEE SYSTEM	Jun 27, 1991	Substantially Equivalent for Some Indications	Depuy, Inc.
K910083	OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES	Apr 01, 1991	Substantially Equivalent	Osteonics Corp.
K903286	CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION	Oct 12, 1990	Substantially Equivalent for Some Indications	Techmedica, Inc.
K900619	CAAS UNICOMPARMENTAL KNEE SYSTEM	Jun 11, 1990	Substantially Equivalent for Some Indications	Techmedica, Inc.
K896648	CONCEPT UNICOMPARTMENTAL KNEE SYSTEM	Jun 05, 1990	Substantially Equivalent for Some Indications	Concept, Inc.
K896856	MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS	Feb 06, 1990	Substantially Equivalent for Some Indications	Osteonics Corp.
K894068	KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM	Dec 08, 1989	Substantially Equivalent for Some Indications	Kirschner Medical Corp.
K881779	WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM	Aug 31, 1988	Substantially Equivalent for Some Indications	Dow Corning Wright
K880155	MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE	Aug 03, 1988	Substantially Equivalent	Zimmer, Inc.
K873970	KIRSCHNER UNICONDYLAR KNEE SYSTEM	Dec 31, 1987	Substantially Equivalent for Some Indications	Kirschner Medical Corp.
K872735	HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.	Aug 04, 1987	Substantially Equivalent	Howmedica Corp.
K862632	INSALL/BURSTEIN(TM)* II TIBIAL WEDGES	Mar 25, 1987	Substantially Equivalent	Zimmer, Inc.
K862837	OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM	Dec 22, 1986	Substantially Equivalent for Some Indications	Osteonics Corp.
K862136	MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE	Jul 14, 1986	Substantially Equivalent	Dow Corning Wright
K861715	WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS	Jul 14, 1986	Substantially Equivalent	Dow Corning Wright
K854325	TRICON UNICOMPARTMENTAL KNEE SYSTEM	Dec 09, 1985	Substantially Equivalent	Richards Medical Co., Inc.
K853020	POROCOAT SYNATOMIC UNICONDYLAR KNEE	Nov 25, 1985	Substantially Equivalent for Some Indications	Depuy, Inc.
K853268	FREEMAN UNI-COMPARTMENTAL KNEE	Sep 04, 1985	Substantially Equivalent	Protek, Inc.
K844706	TRICON REVISION TOTAL KNEE SYSTEM	Feb 19, 1985	Substantially Equivalent	Richards Medical Co., Inc.
K844355	SYNATOMIC STANDARD TIBIAL PLATEAU	Feb 07, 1985	Substantially Equivalent	Depuy, Inc.
K831513	KENNEDY TIBIAL COMPONENT	Jul 28, 1983	Substantially Equivalent	Biomet, Inc.
K803235	GEO-TIBIAL RETAINER ROTATIONAL	Feb 04, 1981	Substantially Equivalent	Zimmer, Inc.
K800640	MEDICAL COMPARTMENT KNEE PROSTHESIS	Apr 21, 1980	Substantially Equivalent	Dow Corning Wright
K792240	POLYCENTRIC TOTAL KNEE METAL TIBIAL	Dec 05, 1979	Substantially Equivalent	Howmedica Corp.
K771511	TOTAL KNEE PROSTHESIS-NONCONSTRAINED	Nov 30, 1977	Substantially Equivalent	3M Company