HSX · Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Orthopedic · 21 CFR 888.3520 · Class 2
Overview
| Product Code | HSX |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Regulation | 21 CFR 888.3520 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (114)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Apr 2, 2026 | SESE |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | Dec 16, 2025 | SESE |
| K251834 | Persona Partial Knee | Zimmer Biomet | Aug 15, 2025 | SESE |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | Jul 24, 2025 | SESE |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | Jul 1, 2025 | SESE |
| K241260 | ACTIFY Unicondylar Knee System | Globus Medical, Inc. | Dec 6, 2024 | SESE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | Oct 30, 2024 | SESE |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | Oct 7, 2024 | SESE |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | Apr 4, 2024 | SESE |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | Mar 10, 2023 | SESE |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | Jun 16, 2022 | SESE |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | Jun 2, 2022 | SESE |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | Dec 16, 2021 | SESE |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | Nov 16, 2021 | SESE |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Oct 12, 2021 | SESE |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | Sep 16, 2021 | SESE |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Aug 20, 2021 | SESE |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Mar 12, 2021 | SESE |
| K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | Jan 8, 2021 | SESE |
| K203099 | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Oct 27, 2020 | SESE |
| K202207 | Materialise PKA Guide System | Materialise NV | Oct 2, 2020 | SESE |
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | Mar 17, 2020 | SESE |
| 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 | Zimmer, Inc. | Mar 17, 2020 | SESE |
| K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Dec 5, 2019 | SESE |
| K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | Oct 8, 2019 | SESE |
| K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | Jul 25, 2019 | SESE |
| K191325 | EMPOWR Partial Knee | Encore Medical L.P. | Jul 16, 2019 | SESE |
| K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | Feb 11, 2019 | SESE |
| K183029 | MOTO Partial Knee System | Medacta International S.A. | Jan 30, 2019 | SESE |
| K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | Jan 17, 2019 | SESE |
| K173970 | Materialise PKA Guide System | Materialise NV | Jul 6, 2018 | SESE |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Jun 7, 2018 | SESE |
| K172650 | Materialise PKA Guide System | Materialise NV | Nov 20, 2017 | SESE |
| K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | Oct 5, 2017 | SESE |
| K161741 | GMK UNI | Medacta International S.A. | Apr 14, 2017 | SESE |
| K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | Mar 29, 2017 | SESE |
| K162084 | MOTO Partial Knee System | Medacta International S.A. | Jan 3, 2017 | SESE |
| K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | Arthrex, Inc. | Dec 15, 2016 | SESE |
| K161592 | Persona Partial Knee System | Biomet, Inc. | Nov 3, 2016 | SESE |
| K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | Jun 15, 2016 | SESE |
| K152315 | JOURNEY II Uni Tibial Base and Insert | Smith & Nephew, Inc. | Oct 28, 2015 | SESE |
| K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | Dec 5, 2013 | SESE |
| K123380 | STRIDE UNICONDYLAR KNEE | Blue Belt Technologies, Inc. | May 31, 2013 | SESE |
| K122529 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE | Zimmer, Inc. | Nov 16, 2012 | SESE |
| K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | Sep 6, 2012 | SESE |
| K120262 | HLS UNI EVOLUTION & U-KNEETEC | Tornier, Inc. | Jul 25, 2012 | SESE |
| K112301 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER | Materialise NV | Jan 6, 2012 | SESE |
| K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | Jan 5, 2012 | SESE |
| K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | Sep 29, 2011 | SESE |
| K102069 | JOURNEY UNICONDYLAR TIBIAL BASEPLATES | Smith & Nephew, Inc. | Oct 5, 2010 | SESE |
| K101206 | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM | Alexandria Research Technologies, LLC | Jul 23, 2010 | SESE |
| K100197 | GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS | Smith & Nephew, Inc. | Feb 19, 2010 | SESE |
| K092441 | MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM | Conformis, Inc. | Sep 9, 2009 | SESE |
| K090024 | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM | Alexandria Research Technologies, LLC | May 4, 2009 | SESE |
| K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | Mako Surgical Corporation | Nov 28, 2008 | SESE |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III | Mako Surgical Corp. | Oct 15, 2008 | SESE |
| K081351 | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT | Smith & Nephew, Inc. | Jul 24, 2008 | SESE |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | Jun 20, 2008 | SESE |
| K073175 | JOURNEY UNICONDYLAR FEMORAL IMPLANT | Smith & Nephew, Inc. | Dec 20, 2007 | SESE |
| K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | Dec 12, 2007 | SESE |
| K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM | Conformis, Inc. | Nov 8, 2007 | SESE |
| K072368 | CONFORMIS METAL BACKED TIBIAL COMPONENT | Conformis, Inc. | Sep 20, 2007 | SESE |
| K063432 | CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) | Conformis, Inc. | Mar 16, 2007 | SESE |
| K063782 | ACCIN UNI-KNEE SYSTEM | Accin Corporation | Jan 19, 2007 | SESE |
| K061779 | COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE | Smith & Nephew, Inc. | Aug 4, 2006 | SESE |
| K061011 | COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE | Smith & Nephew, Inc. | Jul 11, 2006 | SESE |
| K060670 | ACCIN UNI-KNEE SYSTEM | Accin Corporation | Jun 2, 2006 | SESE |
| K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | Feb 23, 2006 | SESE |
| K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | Arthrosurface, Inc. | Oct 11, 2005 | SESE |
| K043570 | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD | Conformis, Inc. | Mar 14, 2005 | SESE |
| K033769 | EIUS UNICOMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | Feb 13, 2004 | SESE |
| K033363 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM | Zimmer, Inc. | Jan 16, 2004 | SESE |
| K032824 | STELKAST UNICONDYLAR KNEE SYSTEM | Stelkast Company | Nov 13, 2003 | SESE |
| K022211 | HLS UNI EVOLUTION PROSTHESIS | Tornier | May 22, 2003 | SESE |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | Sulzer Orthopedics, Inc. | Sep 19, 2001 | SESE |
| K010685 | MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) | Zimmer, Inc. | Apr 2, 2001 | SESE |
| K992287 | FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | Nov 16, 1999 | SESE |
| K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | Link America, Inc. | Jan 26, 1996 | SESE |
| K952068 | ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES | Zimmer, Inc. | Sep 19, 1995 | SESE |
| K942263 | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM | Zimmer, Inc. | Jul 11, 1995 | SN |
| K945613 | DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT | Howmedica Corp. | Mar 6, 1995 | SN |
| K941606 | PRESERVATION UNICOMPARTMENTAL KNEE | Depuy, Inc. | Oct 14, 1994 | SESE |
| K931214 | P.C.A. MODULAR KNEE SYSTEM | Howmedica Corp. | Feb 15, 1994 | SESE |
| K926231 | DURACON UNICOMPARTMENTAL KNEE SYSTEM | Howmedica Corp. | Mar 30, 1993 | SESE |
| K922824 | KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM | Joint Medical Products Corp. | Sep 17, 1992 | SESE |
| K921232 | KEANE UNI KNEE SYSTEM WITH POROCOAT | Depuy, Inc. | Jun 9, 1992 | SESE |
| K915240 | NATURAL-KNEE TIBIAL AND FEMORAL SPACERS | Intermedics Orthopedics | Jan 31, 1992 | SESE |
| K912735 | GENESIS UNICOMPARTMENTAL KNEE SYSTEM | Smith & Nephew Richards, Inc. | Dec 27, 1991 | SN |
| K914439 | P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL | Johnson & Johnson Orthopaedics, Inc. | Oct 23, 1991 | SESE |
| K910807 | KEANE UNI KNEE SYSTEM | Depuy, Inc. | Jun 27, 1991 | SN |
| K910083 | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES | Osteonics Corp. | Apr 1, 1991 | SESE |
| K903286 | CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION | Techmedica, Inc. | Oct 12, 1990 | SN |
| K900619 | CAAS UNICOMPARMENTAL KNEE SYSTEM | Techmedica, Inc. | Jun 11, 1990 | SN |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Concept, Inc. | Jun 5, 1990 | SN |
| K896856 | MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS | Osteonics Corp. | Feb 6, 1990 | SN |
| K894068 | KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM | Kirschner Medical Corp. | Dec 8, 1989 | SN |
| K881779 | WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM | Dow Corning Wright | Aug 31, 1988 | SN |
| K880155 | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE | Zimmer, Inc. | Aug 3, 1988 | SESE |
| K873970 | KIRSCHNER UNICONDYLAR KNEE SYSTEM | Kirschner Medical Corp. | Dec 31, 1987 | SN |
| K872735 | HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. | Howmedica Corp. | Aug 4, 1987 | SESE |
| K862632 | INSALL/BURSTEIN(TM)* II TIBIAL WEDGES | Zimmer, Inc. | Mar 25, 1987 | SESE |
| K862837 | OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM | Osteonics Corp. | Dec 22, 1986 | SN |
| K862136 | MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE | Dow Corning Wright | Jul 14, 1986 | SESE |
| K861715 | WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS | Dow Corning Wright | Jul 14, 1986 | SESE |
| K854325 | TRICON UNICOMPARTMENTAL KNEE SYSTEM | Richards Medical Co., Inc. | Dec 9, 1985 | SESE |
| K853020 | POROCOAT SYNATOMIC UNICONDYLAR KNEE | Depuy, Inc. | Nov 25, 1985 | SN |
| K853268 | FREEMAN UNI-COMPARTMENTAL KNEE | Protek, Inc. | Sep 4, 1985 | SESE |
| K844706 | TRICON REVISION TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | Feb 19, 1985 | SESE |
| K844355 | SYNATOMIC STANDARD TIBIAL PLATEAU | Depuy, Inc. | Feb 7, 1985 | SESE |
| K831513 | KENNEDY TIBIAL COMPONENT | Biomet, Inc. | Jul 28, 1983 | SESE |
| K803235 | GEO-TIBIAL RETAINER ROTATIONAL | Zimmer, Inc. | Feb 4, 1981 | SESE |
| K800640 | MEDICAL COMPARTMENT KNEE PROSTHESIS | Dow Corning Wright | Apr 21, 1980 | SESE |
| K792240 | POLYCENTRIC TOTAL KNEE METAL TIBIAL | Howmedica Corp. | Dec 5, 1979 | SESE |
| K771511 | TOTAL KNEE PROSTHESIS-NONCONSTRAINED | 3M Company | Nov 30, 1977 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 13 clearances
- Zimmer, Inc. — 9 clearances
- Conformis, Inc. — 8 clearances
- Bodycad Laboratories, Inc. — 7 clearances
- Medacta International S.A. — 5 clearances
