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 2017-05-31

Empowr CR Knee Tibial Insert

Applicant Encore Medical L.P.

K number K170573

View details →

JWH 2017-05-22

Smith & Nephew VISIONAIRE Adaptive Guides

Applicant Smith & Nephew, Inc.

K number K170282

View details →

JWH 2017-05-11

ANTHEM CR Total Knee System

Applicant Smith & Nephew, Inc.

K number K170648

View details →

JWH 2017-04-28

Exactech® Truliant™ Line Extensions

Applicant Exactech, Inc.

K number K171045

View details →

JWH 2017-04-26

Apex Revision Knee System

Applicant Omnilife Science

K number K163332

View details →

JWH 2017-03-16

U2 Total Knee System E-XPE products

Applicant United Orthopedic Corporation

K number K161705

View details →

JWH 2017-03-06

GMK Sphere

Applicant Medacta International S.A.

K number K162035

View details →

JWH 2017-03-01

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

Applicant Microport Orthopedics, Inc.

K number K162026

View details →

JWH 2017-02-23

Truliant Femoral Components

Applicant Exactech, Inc.

K number K170240

View details →

JWH 2017-02-01

U2 Total Knee System, PSA Tibial Insert

Applicant United Orthopedic Corporation

K number K161360

View details →

JWH 2017-01-19

Anatomic Total Knee System

Applicant Amplitude

K number K161414

View details →

JWH 2017-01-13

Legion Cone System

Applicant Smith & Nephew, Inc.

K number K162775

View details →

JWH 2016-12-19

Destiknee Total Knee System

Applicant Meril Healthcare Private Limited

K number K160771

View details →

JWH 2016-12-19

PS2 Knee System

Applicant Consensus Orthopedics, Inc.

K number K160515

View details →

JWH 2016-12-01

LOSPA Modular Knee System

Applicant Corentec Co., Ltd.

K number K160157

View details →

JWH 2016-11-07

Materialise TKA Guide System

Applicant Materialise NV

K number K162273

View details →

JWH 2016-10-28

Klassic Knee System

Applicant Total Joint Orthopedics, Inc.

K number K162422

View details →

JWH 2016-09-23

EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)

Applicant Encore Medical L.P.

K number K161945

View details →

JWH 2016-09-07

GENflex2 Total Knee System

Applicant Stelkast, Inc.

K number K162222

View details →

JWH 2016-09-06

Active-X Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K number K160159

View details →

JWH 2016-07-15

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

Applicant Conformis, Inc.

K number K161668

View details →

JWH 2016-06-14

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

Applicant Conformis, Inc.

K number K161366

View details →

JWH 2016-06-10

ATTUNE Revision Knee System

Applicant Depuy(Ireland)

K number K160700

View details →

JWH 2016-05-19

EMPOWR PS Knee System

Applicant Encore Medical L.P.

K number K160342

View details →

JWH 2016-04-12

All Poly Tibial Component

Applicant United Orthopedic Corporation

K number K152430

View details →

JWH 2016-03-25

iTotal Cruciate Retaining (CR) Knee Replacement System

Applicant Conformis, Inc.

K number K153721

View details →

JWH 2016-03-25

Optetrak Logic Metaphyseal Cones

Applicant Exactech, Inc.

K number K153595

View details →

JWH 2016-03-18

Optetrak Advanced Patella

Applicant Exactech, Inc.

K number K160484

View details →

JWH 2016-03-07

iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System

Applicant Conformis, Inc.

K number K160025

View details →

JWH 2016-01-07

ConforMIS iTotal Posterior Stabilized Knee Replacement System

Applicant Conformis, Inc.

K number K153217

View details →

JWH 2013-12-20

GMK SHORT STEM

Applicant Medacta International

K number K133630

View details →

JWH 2013-12-17

ARTHREX IBALANCE TKA SYSTEM

Applicant Arthrex, Inc.

K number K133342

View details →

JWH 2013-12-11

SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS

Applicant Smith & Nephew, Inc.

K number K130708

View details →

JWH 2013-10-30

U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER

Applicant United Orthopedic Corporation

K number K131116

View details →

JWH 2013-10-23

EVOLUTION MP ADAPTIVE PS TIBIAL INSERT

Applicant Wrightmedicaltechnologyinc

K number K131679

View details →

JWH 2013-10-11

OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS

Applicant Exactech, Inc.

K number K132161

View details →

JWH 2013-10-11

BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA

Applicant Ortho Development Corp.

K number K131337

View details →

JWH 2013-10-08

APEX KNEE MODULAR TIBIA SYSTEM

Applicant Omni Life Science, Inc.

K number K131472

View details →

JWH 2013-10-03

NEO KNEE SYSTEM

Applicant Pipeline Orthopedics

K number K131368

View details →

JWH 2013-09-23

PIPELINE KNEE SYSTEM

Applicant Pipeline Orthopedics

K number K132046

View details →

JWH 2013-09-16

NOVOKNEE TOTAL KNEE SYSTEM

Applicant Novosource, Inc.

K number K131398

View details →

JWH 2013-09-13

CAS PSI KNEE SYSTEM

Applicant Orthosoft, Inc.

K number K131409

View details →

JWH 2013-08-22

GMK FULL PE TIBIAL COMPONENTS

Applicant Medacta International

K number K131310

View details →

JWH 2013-08-05

EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

Applicant Stelkast Company

K number K122883

View details →

JWH 2013-07-26

GMK REVISION EXTENSION

Applicant Medacta International

K number K123721

View details →

JWH 2013-07-18

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K131467

View details →

JWH 2013-05-24

ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K131019

View details →

JWH 2013-05-24

PIPELINE KNEE SYSTEM

Applicant Pipeline Orthopedics

K number K123692

View details →

JWH 2013-05-03

MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM

Applicant Tgm Medical, Inc.

K number K130084

View details →

JWH 2013-05-03

SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS

Applicant Smith & Nephew, Inc.

K number K123159

View details →

JWH 2013-05-03

NEO PS KNEE SYSTEM

Applicant Pipeline Orthopedics

K number K122500

View details →

JWH 2013-04-15

LOSPA TOTAL KNEE REPLACEMENT SYSTEM

Applicant Corentec Co., Ltd.

K number K130673

View details →

JWH 2013-04-11

TK1 TOTAL KNEE SYSTEM

Applicant Novosource, Inc.

K number K123339

View details →

JWH 2013-04-11

FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING

Applicant Encore Medical L.P.

K number K122239

View details →

JWH 2013-03-22

BALANCED KNEE SYSTEM HIGH FLEX PS

Applicant Ortho Development Corp.

K number K123457

View details →

JWH 2013-03-20

OPTETRAK LOGIC POROUS FEMORAL COMPONENT

Applicant Exactech, Inc.

K number K123687

View details →

JWH 2013-02-22

PERSONA NATURAL TIBIA BASEPLATES

Applicant Zimmer, Inc.

K number K130143

View details →

JWH 2013-02-14

TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P

Applicant Howmedica Osteonics Corp.

K number K123166

View details →

JWH 2013-02-05

AUGMENT AND SCREW, PSA TYPE

Applicant United Orthopedic Corp.

K number K122183

View details →

JWH 2013-01-14

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K122870

View details →

JWH 2013-01-10

OPTETRAK LOGIC CRC TIBIAL INSERT

Applicant Exactech, Inc.

K number K123342

View details →

JWH 2012-12-20

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K122991

View details →

JWH 2012-12-20

GKS PRIME FLEX CR TOTAL KNEE SYSTEM

Applicant Permedica

K number K122975

View details →

JWH 2012-12-17

COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM

Applicant Aesculap Implant Systems, LLC

K number K120955

View details →

JWH 2012-12-05

ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM

Applicant Materialise NV

K number K121640

View details →

JWH 2012-11-09

PERSONA NATURAL TIBIA BASEPLATES

Applicant Zimmer, Inc.

K number K122765

View details →

JWH 2012-10-26

COLUMBUS REVISION KNEE SYSTEM

Applicant Aesculap Implant System, Inc.

K number K122985

View details →

JWH 2012-09-28

GMK NARROW

Applicant Medacta International

K number K122232

View details →

JWH 2012-09-27

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K122033

View details →

JWH 2012-09-10

UNITY TOATAL KNEE SYSTEM

Applicant Corin USA

K number K113060

View details →

JWH 2012-08-13

JOURNEY II CR KNEE SYSTEM

Applicant Smith & Nephew, Inc.

K number K121443

View details →

JWH 2012-07-27

VEGA KNEE SYSTEM

Applicant Aesculap Implant Systems

K number K121879

View details →

JWH 2012-07-20

DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE

Applicant Encore Medical L.P.

K number K121835

View details →

JWH 2012-07-20

GMK SPHERE

Applicant Medacta International

K number K121416

View details →

JWH 2012-06-29

FREEDOM(R) STEMMED TIBIAL COMPONENTS

Applicant Maxx Orthopedics, Inc.

K number K111785

View details →

JWH 2012-06-08

GMK - LINE EXTENSION

Applicant Medacta International

K number K120790

View details →

JWH 2012-05-31

OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ

Applicant Exactech, Inc.

K number K121307

View details →

JWH 2012-05-18

GENESIS II PS NON-MODULAR FEMORAL COMPONENT

Applicant Smith & Nephew, Inc.

K number K120698

View details →

JWH 2012-05-16

VANGUARD SSK 360 REVISION KNEE SYSTEM

Applicant Biomet Manufacturing Corp

K number K121149

View details →

JWH 2012-05-04

UNITED U2 FEMORAL COMPONENT, PS, #7

Applicant United Orthopedic Corporation

K number K120507

View details →

JWH 2012-05-03

LOSPA TIBIAL BASE PLATE

Applicant Corentec Co., Ltd.

K number K121037

View details →

JWH 2012-04-20

NEO CR KNEE SYSTEM

Applicant Pipeline Orthopedics

K number K120313

View details →

JWH 2012-04-19

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K120316

View details →

JWH 2012-04-02

ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE

Applicant Materialise NV

K number K113829

View details →

JWH 2012-03-27

ZIMMER PERSONA KNEE SYSTEM

Applicant Zimmer, Inc.

K number K113369

View details →

JWH 2012-03-20

PIPELINE CR PRIMARY KNEE SYSTEM

Applicant Pipeline Orthopedics

K number K113122

View details →

JWH 2012-02-29

VANGUARD COMPLETE KNEE SYSTEM

Applicant Biomet Manufacturing Corp

K number K113550

View details →

JWH 2012-02-29

APEX REVISION KNEE SYSTEMS

Applicant Omni Life Science, Inc.

K number K112891

View details →

JWH 2012-02-27

JOURNEY II DEEP DISHED ARTICULAR INSERTS

Applicant Smith & Nephew, Inc.

K number K113482

View details →

JWH 2012-02-16

EAUM TOTAL KNEE SYSTEM

Applicant Corentec Co., Ltd.

K number K110404

View details →

JWH 2012-02-15

CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K113378

View details →

JWH 2012-02-03

CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)

Applicant Conformis, Inc.

K number K120068

View details →

JWH 2012-02-01

KLASSIC KNEE SYSTEM

Applicant Total Joint Orthopedics, Inc.

K number K112906

View details →

JWH 2012-01-27

GMK RESUFACING PATELLA SIZE 4

Applicant Medacta International

K number K113571

View details →

JWH 2011-12-20

LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS

Applicant Smith & Nephew, Inc.

K number K112941

View details →

JWH 2011-12-15

CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Applicant Conformis, Inc.

K number K112780

View details →

JWH 2011-12-09

EVOLUTION MP ADAPTIVE CS INSERT

Applicant Wrightmedicaltechnologyinc

K number K113325

View details →

JWH 2011-11-04

MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...

Applicant Tgm Medical, Inc.

K number K112285

View details →

JWH 2011-10-13

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS

Applicant Materialise NV

K number K111492

View details →

JWH 2011-09-16

JOURNEY II BCS KNEE SYSTEM

Applicant Smith & Nephew, Inc.

K number K111711

View details →