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 2 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211938 | Physica LMC Knee System | Limacorporate | 2021-07-13 | Special | PDF ↗ |
| K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | 2021-05-18 | Traditional | PDF ↗ |
| K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International S.A. | 2021-05-13 | Traditional | PDF ↗ |
| K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | 2021-05-13 | Traditional | PDF ↗ |
| K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | Conformis, Inc. | 2021-05-12 | Traditional | PDF ↗ |
| K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021-05-06 | Traditional | PDF ↗ |
| K200765 | Genius / Genuin Total Knee System | Biorad Medisys Pvt, Ltd. | 2021-05-05 | Traditional | PDF ↗ |
| K210483 | MOBIO Total Knee System | B-One Ortho, Corp. | 2021-04-21 | Traditional | PDF ↗ |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | United Orthopedic Corporation | 2021-04-21 | Special | PDF ↗ |
| K201611 | Apex Knee System | Omnilife Science | 2021-04-02 | Traditional | PDF ↗ |
| K210551 | Persona Revision Knee System | Zimmer, Inc. | 2021-03-18 | Special | PDF ↗ |
| K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System | Conformis, Inc. | 2021-02-17 | Special | PDF ↗ |
| K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | 2020-12-28 | Traditional | PDF ↗ |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | Conformis, Inc. | 2020-12-22 | Special | PDF ↗ |
| K202684 | GMK Total Knee System - TiNbN Coating | Medacta International S.A. | 2020-12-11 | Traditional | PDF ↗ |
| K200912 | Freedom(R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | 2020-11-18 | Traditional | PDF ↗ |
| K202429 | Mobio Total Knee System | B-One Ortho, Corp. | 2020-10-23 | Traditional | PDF ↗ |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | Total Joint Orthopedics, Inc. | 2020-10-09 | Special | PDF ↗ |
| 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. | 2020-09-18 | Traditional | PDF ↗ |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Corentec Co., Ltd. | 2020-07-30 | Special | PDF ↗ |
| K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-07-10 | Traditional | PDF ↗ |
| K193540 | TRUMATCH Personalized Solutions | DePuy Orthopaedics, Inc. | 2020-06-16 | Traditional | PDF ↗ |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020-06-16 | Traditional | PDF ↗ |
| K200227 | Journey II XR Knee Instrument | Smith & Nephew, Inc. | 2020-06-04 | Traditional | PDF ↗ |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020-05-07 | Special | PDF ↗ |
| K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | 2020-05-07 | Traditional | PDF ↗ |
| K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2020-04-24 | Special | PDF ↗ |
| K200209 | Persona Personalized Knee System | Zimmer, Inc. | 2020-03-24 | Traditional | PDF ↗ |
| K200075 | 3DMetal Diaphyseal Femoral Cones | Medacta International S.A. | 2020-03-13 | Traditional | PDF ↗ |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | Conformis, Inc. | 2020-03-13 | Traditional | PDF ↗ |
| K200407 | LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. | 2020-03-13 | Special | PDF ↗ |
| K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020-01-31 | Traditional | PDF ↗ |
| K193057 | ATTUNE All-Polyethylene Tibia | Depuy Ireland UC | 2020-01-30 | Traditional | PDF ↗ |
| K193223 | Persona Personalized Knee System | Zimmer, Inc. | 2020-01-24 | Traditional | PDF ↗ |
| K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019-12-11 | Traditional | PDF ↗ |
| K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | 2019-11-27 | Traditional | PDF ↗ |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019-11-26 | Special | PDF ↗ |
| K182301 | PFC SIGMA Knee System | DePuy Orthopaedics, Inc. | 2019-11-08 | Traditional | PDF ↗ |
| K192084 | Madison Total Knee System | Implanet, S.A. | 2019-10-22 | Traditional | PDF ↗ |
| K191765 | OMNI TiN Coated Apex Knee System | Omni Life Science, Inc. | 2019-09-25 | Traditional | PDF ↗ |
| K192148 | Freedom Primary PCK | Maxx Orthopedics, Inc. | 2019-09-05 | Special | PDF ↗ |
| K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019-09-05 | Traditional | PDF ↗ |
| K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019-08-22 | Traditional | PDF ↗ |
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019-08-08 | Traditional | PDF ↗ |
| K191192 | SurgTech GENOLL Total Knee System | Surgtech, Inc. | 2019-08-01 | Traditional | PDF ↗ |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019-07-25 | Traditional | PDF ↗ |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | Waldemar Link GmbH & Co. KG | 2019-07-18 | Special | PDF ↗ |
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Renovis Surgical Technologies | 2019-06-20 | Traditional | PDF ↗ |
| K183533 | Unity Total Knee System | Corin U.S.A. Limited | 2019-06-04 | Traditional | PDF ↗ |
| K190068 | Vanguard XP Knee System | Zimmer, Inc. | 2019-06-04 | Traditional | PDF ↗ |
| K182251 | EVOLUTION NitrX Medial-Pivot Knee | Mircoport Orthopedics, Inc. | 2019-05-16 | Traditional | PDF ↗ |
| K190355 | Precision Casting Solutions Total Knee System | Precision Casting Solutions, Inc. | 2019-05-16 | Traditional | PDF ↗ |
| K183583 | Vanguard Complete Knee System | Zimmer, Inc. | 2019-05-10 | Traditional | PDF ↗ |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Tecres S.P.A. | 2019-04-27 | Traditional | PDF ↗ |
| K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019-04-03 | Traditional | PDF ↗ |
| 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. | 2019-03-29 | Traditional | PDF ↗ |
| K183344 | The Progressive Orthopaedic Company Total Knee System II | The Progressive Orthopaedic Company, LLC | 2019-03-18 | Traditional | PDF ↗ |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | Total Joint Orthopedics, Inc. | 2019-03-15 | Special | PDF ↗ |
| K183225 | Stabil Orthopaedic Solutions Total Knee System | Stabil Orthopaedic Solutions, LLC | 2019-02-15 | Traditional | PDF ↗ |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | B-One Ortho, Corp. | 2019-01-28 | Traditional | PDF ↗ |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | Maxx Orthopedics, Inc. | 2019-01-22 | Special | PDF ↗ |
| K181338 | Imboki Knee Instrument System | Signature Orthopaedics Pty, Ltd. | 2019-01-17 | Traditional | PDF ↗ |
| K182125 | EVOLUTION Stemmed CS Femur | Microport Orthopedics, Inc. | 2018-12-06 | Traditional | PDF ↗ |
| K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2018-11-28 | Special | PDF ↗ |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | Ortho Development Corporation | 2018-10-31 | Traditional | PDF ↗ |
| K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018-10-25 | Traditional | PDF ↗ |
| K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2018-10-24 | Traditional | PDF ↗ |
| K181569 | BKS Revision Sleeves System | Ortho Development Corporation | 2018-10-12 | Traditional | PDF ↗ |
| K180446 | b-ONE Total Knee System | B-One Ortho, Corp. | 2018-10-12 | Traditional | PDF ↗ |
| K182370 | Acculoc Total Knee System | Rootloc Co., Ltd. | 2018-09-27 | Special | PDF ↗ |
| K181635 | GMK Sphere CR Tibial Inserts | Medacta International S.A. | 2018-08-23 | Traditional | PDF ↗ |
| K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018-08-23 | Traditional | PDF ↗ |
| K181146 | ASK System | L and K Biomed Corporation Limited | 2018-08-03 | Traditional | PDF ↗ |
| K180930 | EMPOWR VVC TIBIAL INSERT | Encore Medical L.P. | 2018-07-09 | Traditional | PDF ↗ |
| K180493 | A3 Total Knee System | Beijing AK Medical Co., Ltd. | 2018-06-22 | Traditional | PDF ↗ |
| K180743 | Balanced Knee Revision System - Offset Junction Box | Ortho Development Corporation | 2018-06-20 | Traditional | PDF ↗ |
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018-05-16 | Special | PDF ↗ |
| K180750 | World Knee System | Signature Orthopaedics Pty, Ltd. | 2018-04-20 | Special | PDF ↗ |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | 2018-03-29 | Traditional | PDF ↗ |
| K170753 | Acculoc Total Knee System | Rootloc Co., Ltd. | 2018-03-23 | Traditional | PDF ↗ |
| K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | 2018-03-09 | Traditional | PDF ↗ |
| K173723 | EMPOWR Universal Tibial Baseplate | Encore Medical L.P. | 2018-03-05 | Traditional | PDF ↗ |
| K180334 | LEGION Knee System | Smith & Nephew, Inc. | 2018-03-05 | Special | PDF ↗ |
| K173445 | Materialise TKA Guide System | Materialise NV | 2018-02-02 | Traditional | PDF ↗ |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | Stelkast, Inc. | 2018-01-19 | Special | PDF ↗ |
| K173884 | Unity Total Knee System | Corin U.S.A. Limited | 2018-01-17 | Traditional | PDF ↗ |
| K172336 | Smith & Nephew Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2018-01-10 | Special | PDF ↗ |
| K171269 | X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2017-12-28 | Traditional | PDF ↗ |
| K172936 | Destiknee Total Knee System | Meril Healthcare Pvt. , Ltd. | 2017-11-30 | Traditional | PDF ↗ |
| K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | 2017-11-16 | Special | PDF ↗ |
| K170534 | PROLIXUS TOTAL KNEE SYSTEM | Otis Biotech Co., Ltd. | 2017-11-09 | Traditional | PDF ↗ |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017-10-30 | Traditional | PDF ↗ |
| K170106 | MyKnee PPS-Pin Positioners | Medacta International S.A. | 2017-10-20 | Special | PDF ↗ |
| K170149 | 3DMetal Tibial Cones | Medacta International S.A. | 2017-08-18 | Traditional | PDF ↗ |
| K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | 2017-08-09 | Traditional | PDF ↗ |
| K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | 2017-08-08 | Traditional | PDF ↗ |
| K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017-07-28 | Traditional | PDF ↗ |
| K170613 | Genius Total Knee System | Signature Orthopaedics Pty, Ltd. | 2017-07-17 | Traditional | PDF ↗ |
| K170808 | Unity Total Knee System | Corin U.S.A. Limited | 2017-07-13 | Traditional | PDF ↗ |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Depuy(Ireland) | 2017-06-15 | Traditional | PDF ↗ |
Product code JWH · Class II · Orthopedic. Data: openFDA.