FDA Product Code
FDA Product Code JWH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3560
510(k) Clearances — 921 records · page 1 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262057 | GMK Extension | Medacta International SA | 2026-09-15 | Traditional | PDF ↗ |
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026-09-11 | Traditional | PDF ↗ |
| K262293 | EVOLUTION MPX Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2026-09-10 | Traditional | PDF ↗ |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | 2026-09-08 | Traditional | PDF ↗ |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | 2026-09-04 | Traditional | PDF ↗ |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | 2026-09-01 | Traditional | PDF ↗ |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 | Traditional | PDF ↗ |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | 2026-07-31 | Special | PDF ↗ |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 | Traditional | PDF ↗ |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 | Traditional | PDF ↗ |
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 | Special | PDF ↗ |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 | Special | PDF ↗ |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 | Traditional | PDF ↗ |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | 2025-11-19 | Traditional | PDF ↗ |
| K253314 | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 | Special | PDF ↗ |
| K253144 | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 | Special | PDF ↗ |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | 2025-09-25 | Special | PDF ↗ |
| K251554 | Materialise TKA Guide System | Materialise NV | 2025-07-14 | Traditional | PDF ↗ |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025-07-08 | Special | PDF ↗ |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. | 2025-07-02 | Traditional | PDF ↗ |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 | Special | PDF ↗ |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | 2025-05-08 | Traditional | PDF ↗ |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 | Special | PDF ↗ |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 | Special | PDF ↗ |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025-03-24 | Traditional | PDF ↗ |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025-03-13 | Special | PDF ↗ |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Zimmer, Inc. | 2025-03-06 | Traditional | PDF ↗ |
| K244039 | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2025-02-28 | Traditional | PDF ↗ |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | 2025-02-18 | Traditional | PDF ↗ |
| 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 | 2025-02-06 | Traditional | PDF ↗ |
| K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies | 2025-01-14 | Traditional | PDF ↗ |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | 2025-01-13 | Traditional | PDF ↗ |
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | 2024-12-20 | Traditional | PDF ↗ |
| 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 | 2024-12-04 | Traditional | PDF ↗ |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | 2024-11-19 | Special | PDF ↗ |
| K242984 | BKS Revision System | Ortho Development Corp. | 2024-10-25 | Special | PDF ↗ |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Osteoremedies, LLC | 2024-10-02 | Traditional | PDF ↗ |
| K241570 | Unity Total Knee System | Corin U.S.A. Limited | 2024-09-23 | Traditional | PDF ↗ |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-09-12 | Special | PDF ↗ |
| K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024-09-11 | Traditional | PDF ↗ |
| K234044 | ACS® LD FB Knee System | Implantcast GmbH | 2024-09-06 | Traditional | PDF ↗ |
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-08-01 | Special | PDF ↗ |
| 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 | 2024-07-11 | Traditional | PDF ↗ |
| K240863 | Freedom® Total Knee System | Maxx Orthopedics, Inc. | 2024-07-02 | Traditional | PDF ↗ |
| K240327 | UNIKO PointCloud Knee Instruments | Unik Orthopedics, Inc. | 2024-06-27 | Traditional | PDF ↗ |
| K240875 | Unity Knee PS-C Tibial Insert | Corin U.S.A. Limited | 2024-06-26 | Traditional | PDF ↗ |
| K240669 | ACTIFY 3D Total Knee System, ACTIFY Total Knee System | Globus Medical, Inc. | 2024-06-20 | Traditional | PDF ↗ |
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | 2024-04-26 | Traditional | PDF ↗ |
| K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | 2024-04-19 | Traditional | PDF ↗ |
| K232175 | XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co., Ltd. | 2024-04-14 | Traditional | PDF ↗ |
| K234011 | AMF TT Cones | Lima Corporate S.P.A. | 2024-01-18 | Special | PDF ↗ |
| K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K230078 | TRAX® CR Total Knee System | Amplitude | 2023-11-03 | Traditional | PDF ↗ |
| K231947 | EVOLUTION® Cement Keel | Microport Orthopedics, Inc. | 2023-10-31 | Traditional | PDF ↗ |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation | 2023-10-25 | Special | PDF ↗ |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Total Joint Othopedics, Inc. | 2023-09-08 | Special | PDF ↗ |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. | 2023-07-17 | Traditional | PDF ↗ |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Conformis, Inc. | 2023-07-17 | Traditional | PDF ↗ |
| K231037 | MyKnee UNI-ST | Medacta International S.A. | 2023-06-09 | Traditional | PDF ↗ |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-06-02 | Traditional | PDF ↗ |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | Conformis, Inc. | 2023-05-26 | Special | PDF ↗ |
| K230537 | Klassic Knee Revision System | Total Joint Othopedics, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| 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. | 2023-05-04 | Traditional | PDF ↗ |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | Conformis, Inc. | 2023-04-27 | Special | PDF ↗ |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | 2023-04-06 | Traditional | PDF ↗ |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Smith & Nephew, Inc. | 2023-03-30 | Special | PDF ↗ |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | Waldemar Link GmbH & Co. KG | 2023-03-21 | Special | PDF ↗ |
| K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P Dba Enovis | 2023-03-17 | Special | PDF ↗ |
| K230321 | Persona Personalized Knee System | Zimmer, Inc. | 2023-03-08 | Special | PDF ↗ |
| K222570 | COPAL knee moulds | Heraeus Medical GmbH | 2023-02-04 | Traditional | PDF ↗ |
| K223650 | REMEDY Stemmed Knee Spacer | Osteoremedies, LLC | 2023-01-05 | Special | PDF ↗ |
| K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | 2022-11-18 | Traditional | PDF ↗ |
| K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K223062 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2022-11-04 | Special | PDF ↗ |
| K222700 | Tibial baseplate, Tibial insert | United Orthopedic Corporation | 2022-10-06 | Special | PDF ↗ |
| K222431 | b-ONER MOBIO Total Knee System | B-One Ortho, Corp. | 2022-10-06 | Traditional | PDF ↗ |
| K222380 | TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Corentec Co., Ltd. | 2022-08-26 | Special | PDF ↗ |
| K221939 | Cemented Round Patella with JRNY Pegs | Smith & Nephew, Inc. | 2022-07-26 | Special | PDF ↗ |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | 2022-07-26 | Traditional | PDF ↗ |
| K221337 | Materialise TKA Guide System | Materialise NV | 2022-07-05 | Traditional | PDF ↗ |
| K211877 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2022-06-22 | Traditional | PDF ↗ |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | 2022-05-10 | Special | PDF ↗ |
| K220705 | MyKnee R Pin Positioners | Medacta International S.A. | 2022-05-04 | Traditional | PDF ↗ |
| K220896 | Legion Inserts with JRNY Lock | Smith & Nephew, Inc. | 2022-04-26 | Special | PDF ↗ |
| 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. | 2022-04-11 | Special | PDF ↗ |
| K213793 | EMPOWR Revision Knee | Encore Medical L.P. | 2022-04-01 | Traditional | PDF ↗ |
| K213673 | b-ONE MOBIO Total Knee System | B-One Ortho, Corp. | 2022-01-21 | Traditional | PDF ↗ |
| K213381 | Physica system | Lima Corporate S.P.A. | 2021-12-17 | Traditional | PDF ↗ |
| K212034 | LOSPA TKR System | Corentec Co., Ltd. | 2021-12-09 | Traditional | PDF ↗ |
| K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | 2021-11-16 | Traditional | PDF ↗ |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2021-11-10 | Special | PDF ↗ |
| K212129 | Persona® Personalized Knee System | Zimmer Switzerland Manufacturing GmbH | 2021-09-28 | Traditional | PDF ↗ |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | 2021-09-23 | Traditional | PDF ↗ |
| 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 | 2021-09-16 | Special | PDF ↗ |
| K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | Depuy Ireland UC | 2021-08-25 | Traditional | PDF ↗ |
| K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | 2021-08-17 | Special | PDF ↗ |
| K210695 | CPM Medical Consultants Tibial Revision Knee System | Cpm Medical Consultants, LLC | 2021-08-16 | Traditional | PDF ↗ |
| K211664 | GMK Sphere Revision | Medacta International S.A. | 2021-07-29 | Traditional | PDF ↗ |
| K211602 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2021-07-23 | Traditional | PDF ↗ |
Product code JWH · Class II · Orthopedic. Data: openFDA.