JWH · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Orthopedic · 21 CFR 888.3560 · Class 2
Overview
| Product Code | JWH |
|---|---|
| Device Name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (910)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253793 | Materialise TKA Guide System | Materialise NV | Jan 6, 2026 | SESE |
| K252974 | EMPOWR Knee | Encore Medical L.P. | Dec 19, 2025 | SESE |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | Nov 19, 2025 | SESE |
| K253314 | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | Oct 29, 2025 | SESE |
| K253144 | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | Oct 22, 2025 | SESE |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | Sep 25, 2025 | SESE |
| K251554 | Materialise TKA Guide System | Materialise NV | Jul 14, 2025 | SESE |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | Jul 8, 2025 | SESE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. | Jul 2, 2025 | SESE |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | Jun 26, 2025 | SESE |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | May 8, 2025 | SESE |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | Apr 17, 2025 | SESE |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | Apr 2, 2025 | SESE |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | Mar 24, 2025 | SESE |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | Mar 13, 2025 | SESE |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Zimmer, Inc. | Mar 6, 2025 | SESE |
| K244039 | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | Feb 28, 2025 | SESE |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | Feb 18, 2025 | SESE |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 6, 2025 | SESE |
| K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies | Jan 14, 2025 | SESE |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | Jan 13, 2025 | SESE |
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | Dec 20, 2024 | SESE |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Dec 4, 2024 | SESE |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | Nov 19, 2024 | SESE |
| K242984 | BKS Revision System | Ortho Development Corp. | Oct 25, 2024 | SESE |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Osteoremedies, LLC | Oct 2, 2024 | SESE |
| K241570 | Unity Total Knee System | Corin U.S.A. Limited | Sep 23, 2024 | SESE |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | Sep 12, 2024 | SESE |
| K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | Sep 11, 2024 | SESE |
| K234044 | ACS® LD FB Knee System | Implantcast GmbH | Sep 6, 2024 | SESE |
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | Aug 1, 2024 | SESE |
| K241000 | ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; | Depuy Ireland UC | Jul 11, 2024 | SESE |
| K240863 | Freedom® Total Knee System | Maxx Orthopedics, Inc. | Jul 2, 2024 | SESE |
| K240327 | UNIKO PointCloud Knee Instruments | Unik Orthopedics, Inc. | Jun 27, 2024 | SESE |
| K240875 | Unity Knee PS-C Tibial Insert | Corin U.S.A. Limited | Jun 26, 2024 | SESE |
| K240669 | ACTIFY 3D Total Knee System, ACTIFY Total Knee System | Globus Medical, Inc. | Jun 20, 2024 | SESE |
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | Apr 26, 2024 | SESE |
| K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | Apr 19, 2024 | SESE |
| K232175 | XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co., Ltd. | Apr 14, 2024 | SESE |
| K234011 | AMF TT Cones | Lima Corporate S.P.A. | Jan 18, 2024 | SESE |
| K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | Nov 21, 2023 | SESE |
| K230078 | TRAX® CR Total Knee System | Amplitude | Nov 3, 2023 | SESE |
| K231947 | EVOLUTION® Cement Keel | Microport Orthopedics, Inc. | Oct 31, 2023 | SESE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation | Oct 25, 2023 | SESE |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Total Joint Othopedics, Inc. | Sep 8, 2023 | SESE |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Conformis, Inc. | Jul 17, 2023 | SESE |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. | Jul 17, 2023 | SESE |
| K231037 | MyKnee UNI-ST | Medacta International S.A. | Jun 9, 2023 | SESE |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jun 2, 2023 | SESE |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | Conformis, Inc. | May 26, 2023 | SESE |
| K230537 | Klassic Knee Revision System | Total Joint Othopedics, Inc. | May 19, 2023 | SESE |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | Smith & Nephew, Inc. | May 4, 2023 | SESE |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | Conformis, Inc. | Apr 27, 2023 | SESE |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | Apr 6, 2023 | SESE |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Smith & Nephew, Inc. | Mar 30, 2023 | SESE |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | Waldemar Link GmbH & Co. KG | Mar 21, 2023 | SESE |
| K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P Dba Enovis | Mar 17, 2023 | SESE |
| K230321 | Persona Personalized Knee System | Zimmer, Inc. | Mar 8, 2023 | SESE |
| K222570 | COPAL knee moulds | Heraeus Medical GmbH | Feb 4, 2023 | SESE |
| K223650 | REMEDY Stemmed Knee Spacer | Osteoremedies, LLC | Jan 5, 2023 | SESE |
| K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | Nov 18, 2022 | SESE |
| K221479 | Persona Personalized Knee System | Zimmer, Inc. | Nov 17, 2022 | SESE |
| K223062 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | Nov 4, 2022 | SESE |
| K222700 | Tibial baseplate, Tibial insert | United Orthopedic Corporation | Oct 6, 2022 | SESE |
| K222431 | b-ONER MOBIO Total Knee System | B-One Ortho, Corp. | Oct 6, 2022 | SESE |
| K222380 | TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. | Oct 4, 2022 | SESE |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Corentec Co., Ltd. | Aug 26, 2022 | SESE |
| K221939 | Cemented Round Patella with JRNY Pegs | Smith & Nephew, Inc. | Jul 26, 2022 | SESE |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | Jul 26, 2022 | SESE |
| K221337 | Materialise TKA Guide System | Materialise NV | Jul 5, 2022 | SESE |
| K211877 | Klassic Knee System | Total Joint Orthopedics, Inc. | Jun 22, 2022 | SESE |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | May 10, 2022 | SESE |
| K220705 | MyKnee R Pin Positioners | Medacta International S.A. | May 4, 2022 | SESE |
| K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | Apr 26, 2022 | SESE |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) | Signature Orthopaedics Pty, Ltd. | Apr 11, 2022 | SESE |
| K213793 | EMPOWR Revision Knee | Encore Medical L.P. | Apr 1, 2022 | SESE |
| K213673 | b-ONE MOBIO Total Knee System | B-One Ortho, Corp. | Jan 21, 2022 | SESE |
| K213381 | Physica system | Lima Corporate S.P.A. | Dec 17, 2021 | SESE |
| K212034 | LOSPA TKR System | Corentec Co., Ltd. | Dec 9, 2021 | SESE |
| K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | Nov 16, 2021 | SESE |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | Nov 10, 2021 | SESE |
| K212129 | Persona® Personalized Knee System | Zimmer Switzerland Manufacturing GmbH | Sep 28, 2021 | SESE |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | Sep 23, 2021 | SESE |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | Waldemar Link GmbH & Co. KG | Sep 16, 2021 | SESE |
| K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | Depuy Ireland UC | Aug 25, 2021 | SESE |
| K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | Aug 17, 2021 | SESE |
| K210695 | CPM Medical Consultants Tibial Revision Knee System | Cpm Medical Consultants, LLC | Aug 16, 2021 | SESE |
| K211664 | GMK Sphere Revision | Medacta International S.A. | Jul 29, 2021 | SESE |
| K211602 | Klassic Knee System | Total Joint Orthopedics, Inc. | Jul 23, 2021 | SESE |
| K211938 | Physica LMC Knee System | Limacorporate | Jul 13, 2021 | SESE |
| K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | May 18, 2021 | SESE |
| K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International S.A. | May 13, 2021 | SESE |
| K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | May 13, 2021 | SESE |
| K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | Conformis, Inc. | May 12, 2021 | SESE |
| K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | May 6, 2021 | SESE |
| K200765 | Genius / Genuin Total Knee System | Biorad Medisys Pvt, Ltd. | May 5, 2021 | SESE |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | United Orthopedic Corporation | Apr 21, 2021 | SESE |
| K210483 | MOBIO Total Knee System | B-One Ortho, Corp. | Apr 21, 2021 | SESE |
| K201611 | Apex Knee System | Omnilife Science | Apr 2, 2021 | SESE |
| K210551 | Persona Revision Knee System | Zimmer, Inc. | Mar 18, 2021 | SESE |
| K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System | Conformis, Inc. | Feb 17, 2021 | SESE |
| K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | Dec 28, 2020 | SESE |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | Conformis, Inc. | Dec 22, 2020 | SESE |
| K202684 | GMK Total Knee System - TiNbN Coating | Medacta International S.A. | Dec 11, 2020 | SESE |
| K200912 | Freedom(R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | Nov 18, 2020 | SESE |
| K202429 | Mobio Total Knee System | B-One Ortho, Corp. | Oct 23, 2020 | SESE |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | Total Joint Orthopedics, Inc. | Oct 9, 2020 | SESE |
| K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) | Medacta International S.A. | Sep 18, 2020 | SESE |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Corentec Co., Ltd. | Jul 30, 2020 | SESE |
| K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jul 10, 2020 | SESE |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | Jun 16, 2020 | SESE |
| K193540 | TRUMATCH Personalized Solutions | DePuy Orthopaedics, Inc. | Jun 16, 2020 | SESE |
| K200227 | Journey II XR Knee Instrument | Smith & Nephew, Inc. | Jun 4, 2020 | SESE |
| K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | May 7, 2020 | SESE |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | May 7, 2020 | SESE |
| K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | Apr 24, 2020 | SESE |
| K200209 | Persona Personalized Knee System | Zimmer, Inc. | Mar 24, 2020 | SESE |
| K200407 | LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. | Mar 13, 2020 | SESE |
| K200075 | 3DMetal Diaphyseal Femoral Cones | Medacta International S.A. | Mar 13, 2020 | SESE |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | Conformis, Inc. | Mar 13, 2020 | SESE |
| K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | Jan 31, 2020 | SESE |
| K193057 | ATTUNE All-Polyethylene Tibia | Depuy Ireland UC | Jan 30, 2020 | SESE |
| K193223 | Persona Personalized Knee System | Zimmer, Inc. | Jan 24, 2020 | SESE |
| K192507 | LOSPA II Knee System | Corentec Co., Ltd. | Dec 11, 2019 | SESE |
| K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | Nov 27, 2019 | SESE |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | Nov 26, 2019 | SESE |
| K182301 | PFC SIGMA Knee System | DePuy Orthopaedics, Inc. | Nov 8, 2019 | SESE |
| K192084 | Madison Total Knee System | Implanet, S.A. | Oct 22, 2019 | SESE |
| K191765 | OMNI TiN Coated Apex Knee System | Omni Life Science, Inc. | Sep 25, 2019 | SESE |
| K192148 | Freedom Primary PCK | Maxx Orthopedics, Inc. | Sep 5, 2019 | SESE |
| K191625 | Persona Revision Knee System | Zimmer, Inc. | Sep 5, 2019 | SESE |
| K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | Aug 22, 2019 | SESE |
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | Aug 8, 2019 | SESE |
| K191192 | SurgTech GENOLL Total Knee System | Surgtech, Inc. | Aug 1, 2019 | SESE |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | Jul 25, 2019 | SESE |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | Waldemar Link GmbH & Co. KG | Jul 18, 2019 | SESE |
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Renovis Surgical Technologies | Jun 20, 2019 | SESE |
| K190068 | Vanguard XP Knee System | Zimmer, Inc. | Jun 4, 2019 | SESE |
| K183533 | Unity Total Knee System | Corin U.S.A. Limited | Jun 4, 2019 | SESE |
| K190355 | Precision Casting Solutions Total Knee System | Precision Casting Solutions, Inc. | May 16, 2019 | SESE |
| K182251 | EVOLUTION NitrX Medial-Pivot Knee | Mircoport Orthopedics, Inc. | May 16, 2019 | SESE |
| K183583 | Vanguard Complete Knee System | Zimmer, Inc. | May 10, 2019 | SESE |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Tecres S.P.A. | Apr 27, 2019 | SESE |
| K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | Apr 3, 2019 | SESE |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | Total Joint Orthopedics, Inc. | Mar 29, 2019 | SESE |
| K183344 | The Progressive Orthopaedic Company Total Knee System II | The Progressive Orthopaedic Company, LLC | Mar 18, 2019 | SESE |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | Total Joint Orthopedics, Inc. | Mar 15, 2019 | SESE |
| K183225 | Stabil Orthopaedic Solutions Total Knee System | Stabil Orthopaedic Solutions, LLC | Feb 15, 2019 | SESE |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | B-One Ortho, Corp. | Jan 28, 2019 | SESE |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | Maxx Orthopedics, Inc. | Jan 22, 2019 | SESE |
| K181338 | Imboki Knee Instrument System | Signature Orthopaedics Pty, Ltd. | Jan 17, 2019 | SESE |
| K182125 | EVOLUTION Stemmed CS Femur | Microport Orthopedics, Inc. | Dec 6, 2018 | SESE |
| K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | Nov 28, 2018 | SESE |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | Ortho Development Corporation | Oct 31, 2018 | SESE |
| K181947 | Persona Revision Knee System | Zimmer, Inc. | Oct 25, 2018 | SESE |
| K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | Oct 24, 2018 | SESE |
| K181569 | BKS Revision Sleeves System | Ortho Development Corporation | Oct 12, 2018 | SESE |
| K180446 | b-ONE Total Knee System | B-One Ortho, Corp. | Oct 12, 2018 | SESE |
| K182370 | Acculoc Total Knee System | Rootloc Co., Ltd. | Sep 27, 2018 | SESE |
| K181635 | GMK Sphere CR Tibial Inserts | Medacta International S.A. | Aug 23, 2018 | SESE |
| K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | Aug 23, 2018 | SESE |
| K181146 | ASK System | L and K Biomed Corporation Limited | Aug 3, 2018 | SESE |
| K180930 | EMPOWR VVC TIBIAL INSERT | Encore Medical L.P. | Jul 9, 2018 | SESE |
| K180493 | A3 Total Knee System | Beijing AK Medical Co., Ltd. | Jun 22, 2018 | SESE |
| K180743 | Balanced Knee Revision System - Offset Junction Box | Ortho Development Corporation | Jun 20, 2018 | SESE |
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | May 16, 2018 | SESE |
| K180750 | World Knee System | Signature Orthopaedics Pty, Ltd. | Apr 20, 2018 | SESE |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | Mar 29, 2018 | SESE |
| K170753 | Acculoc Total Knee System | Rootloc Co., Ltd. | Mar 23, 2018 | SESE |
| K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | Mar 9, 2018 | SESE |
| K180334 | LEGION Knee System | Smith & Nephew, Inc. | Mar 5, 2018 | SESE |
| K173723 | EMPOWR Universal Tibial Baseplate | Encore Medical L.P. | Mar 5, 2018 | SESE |
| K173445 | Materialise TKA Guide System | Materialise NV | Feb 2, 2018 | SESE |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | Stelkast, Inc. | Jan 19, 2018 | SESE |
| K173884 | Unity Total Knee System | Corin U.S.A. Limited | Jan 17, 2018 | SESE |
| K172336 | Smith & Nephew Patient Matched Cutting Blocks | Smith & Nephew, Inc. | Jan 10, 2018 | SESE |
| K171269 | X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | Dec 28, 2017 | SESE |
| K172936 | Destiknee Total Knee System | Meril Healthcare Pvt. , Ltd. | Nov 30, 2017 | SESE |
| K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | Nov 16, 2017 | SESE |
| K170534 | PROLIXUS TOTAL KNEE SYSTEM | Otis Biotech Co., Ltd. | Nov 9, 2017 | SESE |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | Oct 30, 2017 | SESE |
| K170106 | MyKnee PPS-Pin Positioners | Medacta International S.A. | Oct 20, 2017 | SESE |
| K170149 | 3DMetal Tibial Cones | Medacta International S.A. | Aug 18, 2017 | SESE |
| K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | Aug 9, 2017 | SESE |
| K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | Aug 8, 2017 | SESE |
| K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | Jul 28, 2017 | SESE |
| K170613 | Genius Total Knee System | Signature Orthopaedics Pty, Ltd. | Jul 17, 2017 | SESE |
| K170808 | Unity Total Knee System | Corin U.S.A. Limited | Jul 13, 2017 | SESE |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Depuy(Ireland) | Jun 15, 2017 | SESE |
| K170573 | Empowr CR Knee Tibial Insert | Encore Medical L.P. | May 31, 2017 | SESE |
| K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | Smith & Nephew, Inc. | May 22, 2017 | SESE |
| K170648 | ANTHEM CR Total Knee System | Smith & Nephew, Inc. | May 11, 2017 | SESE |
| K171045 | Exactech® Truliant Line Extensions | Exactech, Inc. | Apr 28, 2017 | SESE |
| K163332 | Apex Revision Knee System | Omnilife Science | Apr 26, 2017 | SESE |
| K161705 | U2 Total Knee System E-XPE products | United Orthopedic Corporation | Mar 16, 2017 | SESE |
| K162035 | GMK Sphere | Medacta International S.A. | Mar 6, 2017 | SESE |
| K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions | Microport Orthopedics, Inc. | Mar 1, 2017 | SESE |
| K170240 | Truliant Femoral Components | Exactech, Inc. | Feb 23, 2017 | SESE |
| K161360 | U2 Total Knee System, PSA Tibial Insert | United Orthopedic Corporation | Feb 1, 2017 | SESE |
| K161414 | Anatomic Total Knee System | Amplitude | Jan 19, 2017 | SESE |
Top Applicants
- Zimmer, Inc. — 51 clearances
- Smith & Nephew, Inc. — 49 clearances
- Howmedica Corp. — 47 clearances
- Conformis, Inc. — 40 clearances
- Biomet, Inc. — 40 clearances
