Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA product code JWH · 861 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3560
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 2026-09-15

JWH 2026-09-15

GMK Extension

Applicant Medacta International SA

K number K262057

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JWH 2026-09-11

GSPE Spacer

Applicant The General Hospital Corporation, d/b/a Massachusetts

K number K260063

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JWH 2026-09-10

EVOLUTION MPX™ Total Knee System

Applicant Suzhou Microport Orthorecon Co., Ltd.

K number K262293

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JWH 2026-09-08

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

Applicant B-One Ortho, Corp.

K number K262341

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JWH 2026-09-04

ATTUNE Revision Knee System

Applicant Depuy Orthopaedics, Inc.

K number K262130

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JWH 2026-09-01

SK Knee System

Applicant Just Medical Devices (Tianjin) Co., Ltd.

K number K253961

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JWH 2026-08-07

Freedom Total Knee System (E-Poly Tibial Liners)

Applicant Maxx Orthopedics, Inc.

K number K261563

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JWH 2026-07-31

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

Applicant Globus Medical, Inc.

K number K262251

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JWH 2026-07-23

Klassic Infection Spacer System

Applicant Total Joint Orthopedics, Inc.

K number K261734

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JWH 2026-06-25

ATTUNE Total Knee System; ATTUNE Cementless Knee System

Applicant DePuy Ireland UC

K number K261458

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JWH 2026-04-27

NovoKnee (SteriKnee)

Applicant NovoSource

K number K261032

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JWH 2026-01-06

Materialise TKA Guide System

Applicant Materialise NV

K number K253793

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JWH 2025-12-19

EMPOWR Knee

Applicant Encore Medical L.P.

K number K252974

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JWH 2025-11-19

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

Applicant Depuy Ireland UC

K number K253197

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JWH 2025-10-29

Freedom Infinia™ Total Knee System

Applicant Maxx Orthopedics, Inc.

K number K253314

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JWH 2025-10-22

Freedom® Total Knee System – Titan PCK Components

Applicant Maxx Orthopedics, Inc.

K number K253144

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JWH 2025-09-25

Stem Extension Line (U2 Total Knee System—PSA Type)

Applicant United Orthopedic Corporation

K number K252725

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JWH 2025-07-14

Materialise TKA Guide System

Applicant Materialise NV

K number K251554

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JWH 2025-07-08

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

Applicant Encore Medical L.P.

K number K251776

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JWH 2025-07-02

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

Applicant Encore Medical L.P.

K number K251241

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JWH 2025-06-26

Freedom® Total Knee System – Titanium Tibial Base Plate

Applicant Maxx Orthopedics, Inc.

K number K251717

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JWH 2025-05-08

NextStep Arthropedix Total Knee System

Applicant Nextstep Arthropedix

K number K242410

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JWH 2025-04-17

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K number K250889

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JWH 2025-04-02

LEGION Total Knee System

Applicant Smith & Nephew, Inc.

K number K250677

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JWH 2025-03-24

Klassic Knee System - Revision Tibial Baseplate

Applicant Total Joint Othopedics, Inc.

K number K243991

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JWH 2025-03-13

Freedom Total Knee System (All-poly Tibial Plate)

Applicant Maxx Orthopedics, Inc.

K number K250382

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JWH 2025-03-06

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)

Applicant Zimmer, Inc.

K number K243724

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JWH 2025-02-28

MedalOne Total Knee System

Applicant Suzhou Microport Orthorecon Co., Ltd.

K number K244039

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JWH 2025-02-18

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

Applicant Microport Orthopedics, Inc.

K number K243574

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JWH 2025-02-06

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

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K243817

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JWH 2025-01-14

Consensus Knee System with TiNbN

Applicant Shalby Advanced Technologies

K number K241180

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JWH 2025-01-13

Initia Knee System

Applicant Kyocera Medical Technologies, Inc.

K number K243295

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JWH 2024-12-20

Cellbrick Knee Spacer

Applicant United Orthopedic Corporation

K number K243024

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JWH 2024-12-04

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

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K242831

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JWH 2024-11-19

Freedom® Medial Congruent Liner

Applicant Maxx Orthopedics, Inc.

K number K243277

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JWH 2024-10-25

BKS Revision System

Applicant Ortho Development Corp.

K number K242984

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JWH 2024-10-02

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

Applicant Osteoremedies, LLC

K number K242377

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JWH 2024-09-23

Unity Total Knee System

Applicant Corin U.S.A. Limited

K number K241570

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JWH 2024-09-12

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K number K242401

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JWH 2024-09-11

Rx Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K number K240683

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JWH 2024-09-06

ACS® LD FB Knee System

Applicant Implantcast GmbH

K number K234044

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JWH 2024-08-01

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K number K242046

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JWH 2024-07-11

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;

Applicant Depuy Ireland UC

K number K241000

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JWH 2024-07-02

Freedom® Total Knee System

Applicant Maxx Orthopedics, Inc.

K number K240863

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JWH 2024-06-27

UNIKO PointCloud™ Knee Instruments

Applicant Unik Orthopedics, Inc.

K number K240327

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JWH 2024-06-26

Unity Knee PS-C Tibial Insert

Applicant Corin U.S.A. Limited

K number K240875

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JWH 2024-06-20

ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System

Applicant Globus Medical, Inc.

K number K240669

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JWH 2024-04-26

EMPOWR Revision Symmetric Knee Cones

Applicant Encore Medical, L.P. (Dba Enovis)

K number K240324

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JWH 2024-04-19

KeYi Total Knee System

Applicant Beijing Keyi Medical Device Technology Co., Ltd.

K number K230120

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JWH 2024-04-14

XN Knee Prosthesis System

Applicant Beijing Chunlizhengda Medical Instruments Co., Ltd.

K number K232175

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JWH 2024-01-18

AMF TT Cones

Applicant Lima Corporate S.P.A.

K number K234011

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JWH 2023-11-21

PNK Total Knee System

Applicant Tjc Life Co., Ltd.

K number K231975

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JWH 2023-11-03

TRAX® CR Total Knee System

Applicant Amplitude

K number K230078

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JWH 2023-10-31

EVOLUTION® Cement Keel

Applicant Microport Orthopedics, Inc.

K number K231947

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JWH 2023-10-25

Balanced Knee® System TriMax PS Plus Tibial Insert

Applicant Ortho Development Corporation

K number K233093

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JWH 2023-09-08

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

Applicant Total Joint Othopedics, Inc.

K number K232414

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JWH 2023-07-17

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System

Applicant Conformis, Inc.

K number K230846

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JWH 2023-07-17

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas

Applicant Exactech, Inc.

K number K223252

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JWH 2023-06-09

MyKnee UNI-ST

Applicant Medacta International S.A.

K number K231037

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JWH 2023-06-02

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K230952

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JWH 2023-05-26

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS

Applicant Conformis, Inc.

K number K231233

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JWH 2023-05-19

Klassic Knee Revision System

Applicant Total Joint Othopedics, Inc.

K number K230537

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JWH 2023-05-04

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

Applicant Smith & Nephew, Inc.

K number K230653

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JWH 2023-04-27

Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert

Applicant Conformis, Inc.

K number K230844

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JWH 2023-04-06

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

Applicant Encore Medical, L.P Dba Enovis

K number K230169

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JWH 2023-03-30

Cemented Tibia Baseplate no Taper with JRNY Lock

Applicant Smith & Nephew, Inc.

K number K230555

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JWH 2023-03-21

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

Applicant Waldemar Link GmbH & Co. KG

K number K230471

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JWH 2023-03-17

EMPOWR Stem Extender, 50mm

Applicant Encore Medical, L.P Dba Enovis

K number K230441

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JWH 2023-03-08

Persona™ Personalized Knee System

Applicant Zimmer, Inc.

K number K230321

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JWH 2023-02-04

COPAL knee moulds

Applicant Heraeus Medical GmbH

K number K222570

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JWH 2023-01-05

REMEDY Stemmed Knee Spacer

Applicant Osteoremedies, LLC

K number K223650

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JWH 2022-11-18

Opulent TiNbN Coated Knee

Applicant Meril Healthcare Pvt. , Ltd.

K number K222816

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JWH 2022-11-17

Persona Personalized Knee System

Applicant Zimmer, Inc.

K number K221479

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JWH 2022-11-04

World Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K number K223062

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JWH 2022-10-06

Tibial baseplate, Tibial insert

Applicant United Orthopedic Corporation

K number K222700

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JWH 2022-10-06

b-ONER MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K number K222431

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JWH 2022-10-04

TriVerse Total Knee Replacement System

Applicant Signature Orthopaedics Pty, Ltd.

K number K222380

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JWH 2022-08-26

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

Applicant Corentec Co., Ltd.

K number K222278

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JWH 2022-07-26

Cemented Round Patella with JRNY Pegs

Applicant Smith & Nephew, Inc.

K number K221939

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JWH 2022-07-26

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K number K221404

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JWH 2022-07-05

Materialise TKA Guide System

Applicant Materialise NV

K number K221337

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JWH 2022-06-22

Klassic Knee System

Applicant Total Joint Orthopedics, Inc.

K number K211877

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JWH 2022-05-10

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K number K221059

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JWH 2022-05-04

MyKnee R Pin Positioners

Applicant Medacta International S.A.

K number K220705

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JWH 2022-04-26

Legion Inserts with JRNY Lock

Applicant Smith & Nephew, Inc.

K number K220896

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JWH 2022-04-11

World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)

Applicant Signature Orthopaedics Pty, Ltd.

K number K220737

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JWH 2022-04-01

EMPOWR Revision Knee

Applicant Encore Medical L.P.

K number K213793

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JWH 2022-01-21

b-ONE MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K number K213673

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JWH 2021-12-17

Physica system

Applicant Lima Corporate S.P.A.

K number K213381

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JWH 2021-12-09

LOSPA TKR System

Applicant Corentec Co., Ltd.

K number K212034

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JWH 2021-11-16

Opulent TiNbN Coated Knee

Applicant Meril Healthcare Pvt. , Ltd.

K number K212839

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JWH 2021-11-10

Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System

Applicant Conformis, Inc.

K number K213389

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JWH 2021-09-28

Persona® Personalized Knee System

Applicant Zimmer Switzerland Manufacturing GmbH

K number K212129

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JWH 2021-09-23

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K number K212411

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JWH 2021-09-16

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

Applicant Waldemar Link GmbH & Co. KG

K number K212742

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JWH 2021-08-25

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

Applicant Depuy Ireland UC

K number K211609

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JWH 2021-08-17

Journey II Mid-Level Tibial Inserts

Applicant Smith & Nephew, Inc.

K number K211671

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JWH 2021-08-16

CPM Medical Consultants Tibial Revision Knee System

Applicant Cpm Medical Consultants, LLC

K number K210695

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JWH 2021-07-29

GMK Sphere Revision

Applicant Medacta International S.A.

K number K211664

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JWH 2021-07-23

Klassic Knee System

Applicant Total Joint Orthopedics, Inc.

K number K211602

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