ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

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

Regulation 888.3560

14510(k)s in 12 months (921 all time)
6recalls in 12 months (984 all time)
887recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
Decided510(k)Device and applicantCode
Sep 15, 2026K262057GMK Extension
Medacta International SA, CH
JWH
Sep 11, 2026K260063GSPE Spacer
The General Hospital Corporation, d/b/a Massachusetts
JWH
Sep 10, 2026K262293EVOLUTION MPX™ Total Knee System
Suzhou Microport Orthorecon Co., Ltd., CN
JWH
Sep 8, 2026K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
B-One Ortho, Corp.
JWH
Sep 4, 2026K262130ATTUNE Revision Knee System
Depuy Orthopaedics, Inc.
JWH
Sep 1, 2026K253961SK Knee System
Just Medical Devices (Tianjin) Co., Ltd., CN
JWH
Aug 7, 2026K261563Freedom Total Knee System (E-Poly Tibial Liners)
Maxx Orthopedics, Inc.
JWH
Jul 31, 2026K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
Globus Medical, Inc.
JWH
Jul 23, 2026K261734Klassic Infection Spacer System
Total Joint Orthopedics, Inc.
JWH
Jun 25, 2026K261458ATTUNE Total Knee System; ATTUNE Cementless Knee System
DePuy Ireland UC, IE
JWH
Apr 27, 2026K261032NovoKnee (SteriKnee)
NovoSource
JWH
Jan 6, 2026K253793Materialise TKA Guide System
Materialise NV, BE
JWH
Dec 19, 2025K252974EMPOWR Knee
Encore Medical L.P.
JWH
Nov 19, 2025K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
Depuy Ireland UC, IE
JWH
Oct 29, 2025K253314Freedom Infinia™ Total Knee System
Maxx Orthopedics, Inc.
JWH
Oct 22, 2025K253144Freedom® Total Knee System – Titan PCK Components
Maxx Orthopedics, Inc.
JWH
Sep 25, 2025K252725Stem Extension Line (U2 Total Knee System—PSA Type)
United Orthopedic Corporation, TW
JWH
Jul 14, 2025K251554Materialise TKA Guide System
Materialise NV, BE
JWH
Jul 8, 2025K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
Encore Medical L.P.
JWH
Jul 2, 2025K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
Encore Medical L.P.
JWH
Jun 26, 2025K251717Freedom® Total Knee System – Titanium Tibial Base Plate
Maxx Orthopedics, Inc.
JWH
May 8, 2025K242410NextStep Arthropedix Total Knee System
Nextstep Arthropedix
JWH
Apr 17, 2025K250889EXULT Knee Replacement System
Corentec Co., Ltd., KR
JWH
Apr 2, 2025K250677LEGION Total Knee System
Smith & Nephew, Inc.
JWH
Mar 24, 2025K243991Klassic Knee System - Revision Tibial Baseplate
Total Joint Othopedics, Inc.
JWH
Mar 13, 2025K250382Freedom Total Knee System (All-poly Tibial Plate)
Maxx Orthopedics, Inc.
JWH
Mar 6, 2025K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
Zimmer, Inc.
JWH
Feb 28, 2025K244039MedalOne Total Knee System
Suzhou Microport Orthorecon Co., Ltd., CN
JWH
Feb 18, 2025K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
Microport Orthopedics, Inc.
JWH
Feb 6, 2025K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpi
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
JWH
Jan 14, 2025K241180Consensus Knee System with TiNbN
Shalby Advanced Technologies
JWH
Jan 13, 2025K243295Initia Knee System
Kyocera Medical Technologies, Inc.
JWH
Dec 20, 2024K243024Cellbrick Knee Spacer
United Orthopedic Corporation, TW
JWH
Dec 4, 2024K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Tria
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
JWH
Nov 19, 2024K243277Freedom® Medial Congruent Liner
Maxx Orthopedics, Inc.
JWH
Oct 25, 2024K242984BKS Revision System
Ortho Development Corp.
JWH
Oct 2, 2024K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
Osteoremedies, LLC
JWH
Sep 23, 2024K241570Unity Total Knee System
Corin U.S.A. Limited
JWH
Sep 12, 2024K242401EXULT Knee Replacement System
Corentec Co., Ltd., KR
JWH
Sep 11, 2024K240683Rx Knee System
Signature Orthopaedics Pty, Ltd., AU
JWH
Sep 6, 2024K234044ACS® LD FB Knee System
Implantcast GmbH, DE
JWH
Aug 1, 2024K242046EXULT Knee Replacement System
Corentec Co., Ltd., KR
JWH
Jul 11, 2024K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal
Depuy Ireland UC, IE
JWH
Jul 2, 2024K240863Freedom® Total Knee System
Maxx Orthopedics, Inc.
JWH
Jun 27, 2024K240327UNIKO PointCloud™ Knee Instruments
Unik Orthopedics, Inc.
JWH
Jun 26, 2024K240875Unity Knee PS-C Tibial Insert
Corin U.S.A. Limited
JWH
Jun 20, 2024K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
Globus Medical, Inc.
JWH
Apr 26, 2024K240324EMPOWR Revision Symmetric Knee Cones
Encore Medical, L.P. (Dba Enovis)
JWH
Apr 19, 2024K230120KeYi Total Knee System
Beijing Keyi Medical Device Technology Co., Ltd., CN
JWH
Apr 14, 2024K232175XN Knee Prosthesis System
Beijing Chunlizhengda Medical Instruments Co., Ltd., CN
JWH

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