FDA Product Code
FDA Product Code HSX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3520
510(k) Clearances — 115 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261609 | Freedom Partial Knee System | Maxx Orthopedics, Inc. | 2026-08-04 | Traditional | PDF ↗ |
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 | Special | PDF ↗ |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025-12-16 | Traditional | PDF ↗ |
| K251834 | Persona Partial Knee | Zimmer Biomet | 2025-08-15 | Traditional | PDF ↗ |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025-07-24 | Traditional | PDF ↗ |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025-07-01 | Traditional | PDF ↗ |
| K241260 | ACTIFY Unicondylar Knee System | Globus Medical, Inc. | 2024-12-06 | Traditional | PDF ↗ |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024-10-30 | Traditional | PDF ↗ |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024-10-07 | Special | PDF ↗ |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | 2024-04-04 | Traditional | PDF ↗ |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023-03-10 | Traditional | PDF ↗ |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022-06-16 | Traditional | PDF ↗ |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022-06-02 | Traditional | PDF ↗ |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | 2021-12-16 | Traditional | PDF ↗ |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021-11-16 | Traditional | PDF ↗ |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-10-12 | Traditional | PDF ↗ |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 | Traditional | PDF ↗ |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-08-20 | Traditional | PDF ↗ |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-03-12 | Special | PDF ↗ |
| K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021-01-08 | Traditional | PDF ↗ |
| K203099 | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2020-10-27 | Traditional | PDF ↗ |
| K202207 | Materialise PKA Guide System | Materialise NV | 2020-10-02 | Traditional | PDF ↗ |
| K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill | Zimmer, Inc. | 2020-03-17 | Traditional | PDF ↗ |
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020-03-17 | Special | PDF ↗ |
| K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019-12-05 | Traditional | PDF ↗ |
| K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-10-08 | Traditional | PDF ↗ |
| K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019-07-25 | Traditional | PDF ↗ |
| K191325 | EMPOWR Partial Knee | Encore Medical L.P. | 2019-07-16 | Traditional | PDF ↗ |
| K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019-02-11 | Special | PDF ↗ |
| K183029 | MOTO Partial Knee System | Medacta International S.A. | 2019-01-30 | Traditional | PDF ↗ |
| K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-01-17 | Abbreviated | PDF ↗ |
| K173970 | Materialise PKA Guide System | Materialise NV | 2018-07-06 | Traditional | PDF ↗ |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2018-06-07 | Traditional | PDF ↗ |
| K172650 | Materialise PKA Guide System | Materialise NV | 2017-11-20 | Traditional | PDF ↗ |
| K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K161741 | GMK UNI | Medacta International S.A. | 2017-04-14 | Traditional | PDF ↗ |
| K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017-03-29 | Traditional | PDF ↗ |
| K162084 | MOTO Partial Knee System | Medacta International S.A. | 2017-01-03 | Traditional | PDF ↗ |
| K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | Arthrex, Inc. | 2016-12-15 | Special | PDF ↗ |
| K161592 | Persona Partial Knee System | Biomet, Inc. | 2016-11-03 | Traditional | PDF ↗ |
| K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016-06-15 | Traditional | PDF ↗ |
| K152315 | JOURNEY II Uni Tibial Base and Insert | Smith & Nephew, Inc. | 2015-10-28 | Special | PDF ↗ |
| K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | 2013-12-05 | Traditional | PDF ↗ |
| K123380 | STRIDE UNICONDYLAR KNEE | Blue Belt Technologies, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K122529 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE | Zimmer, Inc. | 2012-11-16 | Traditional | PDF ↗ |
| K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | 2012-09-06 | Traditional | PDF ↗ |
| K120262 | HLS UNI EVOLUTION & U-KNEETEC | Tornier, Inc. | 2012-07-25 | Traditional | PDF ↗ |
| K112301 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER | Materialise NV | 2012-01-06 | Traditional | PDF ↗ |
| K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | 2012-01-05 | Traditional | PDF ↗ |
| K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | 2011-09-29 | Traditional | PDF ↗ |
| K102069 | JOURNEY UNICONDYLAR TIBIAL BASEPLATES | Smith & Nephew, Inc. | 2010-10-05 | Traditional | PDF ↗ |
| K101206 | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM | Alexandria Research Technologies, LLC | 2010-07-23 | Traditional | PDF ↗ |
| K100197 | GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS | Smith & Nephew, Inc. | 2010-02-19 | Special | PDF ↗ |
| K092441 | MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM | Conformis, Inc. | 2009-09-09 | Special | PDF ↗ |
| K090024 | TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM | Alexandria Research Technologies, LLC | 2009-05-04 | Traditional | PDF ↗ |
| K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | Mako Surgical Corporation | 2008-11-28 | Traditional | PDF ↗ |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III | Mako Surgical Corp. | 2008-10-15 | Traditional | PDF ↗ |
| K081351 | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT | Smith & Nephew, Inc. | 2008-07-24 | Special | PDF ↗ |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-06-20 | Traditional | PDF ↗ |
| K073175 | JOURNEY UNICONDYLAR FEMORAL IMPLANT | Smith & Nephew, Inc. | 2007-12-20 | Abbreviated | PDF ↗ |
| K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | 2007-12-12 | Special | PDF ↗ |
| K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM | Conformis, Inc. | 2007-11-08 | Traditional | PDF ↗ |
| K072368 | CONFORMIS METAL BACKED TIBIAL COMPONENT | Conformis, Inc. | 2007-09-20 | Traditional | PDF ↗ |
| K063432 | CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) | Conformis, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K063782 | ACCIN UNI-KNEE SYSTEM | Accin Corporation | 2007-01-19 | Special | PDF ↗ |
| K061779 | COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE | Smith & Nephew, Inc. | 2006-08-04 | Abbreviated | PDF ↗ |
| K061011 | COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE | Smith & Nephew, Inc. | 2006-07-11 | Abbreviated | PDF ↗ |
| K060670 | ACCIN UNI-KNEE SYSTEM | Accin Corporation | 2006-06-02 | Traditional | PDF ↗ |
| K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | 2006-02-23 | Traditional | PDF ↗ |
| K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2005-10-11 | Traditional | PDF ↗ |
| K043570 | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD | Conformis, Inc. | 2005-03-14 | Traditional | PDF ↗ |
| K033769 | EIUS UNICOMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | 2004-02-13 | Special | PDF ↗ |
| K033363 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM | Zimmer, Inc. | 2004-01-16 | Traditional | PDF ↗ |
| K032824 | STELKAST UNICONDYLAR KNEE SYSTEM | Stelkast Company | 2003-11-13 | Traditional | PDF ↗ |
| K022211 | HLS UNI EVOLUTION PROSTHESIS | Tornier | 2003-05-22 | Traditional | PDF ↗ |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | Sulzer Orthopedics, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K010685 | MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) | Zimmer, Inc. | 2001-04-02 | Special | PDF ↗ |
| K992287 | FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | 1999-11-16 | Traditional | PDF ↗ |
| K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | Link America, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K952068 | ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES | Zimmer, Inc. | 1995-09-19 | Traditional | PDF ↗ |
| K942263 | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM | Zimmer, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K945613 | DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT | Howmedica Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K941606 | PRESERVATION UNICOMPARTMENTAL KNEE | Depuy, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K931214 | P.C.A. MODULAR KNEE SYSTEM | Howmedica Corp. | 1994-02-15 | Traditional | PDF ↗ |
| K926231 | DURACON UNICOMPARTMENTAL KNEE SYSTEM | Howmedica Corp. | 1993-03-30 | Traditional | PDF ↗ |
| K922824 | KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM | Joint Medical Products Corp. | 1992-09-17 | Traditional | PDF ↗ |
| K921232 | KEANE UNI KNEE SYSTEM WITH POROCOAT | Depuy, Inc. | 1992-06-09 | Traditional | PDF ↗ |
| K915240 | NATURAL-KNEE TIBIAL AND FEMORAL SPACERS | Intermedics Orthopedics | 1992-01-31 | Traditional | PDF ↗ |
| K912735 | GENESIS UNICOMPARTMENTAL KNEE SYSTEM | Smith & Nephew Richards, Inc. | 1991-12-27 | Traditional | PDF ↗ |
| K914439 | P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL | Johnson & Johnson Orthopaedics, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K910807 | KEANE UNI KNEE SYSTEM | Depuy, Inc. | 1991-06-27 | Traditional | PDF ↗ |
| K910083 | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES | Osteonics Corp. | 1991-04-01 | Traditional | PDF ↗ |
| K903286 | CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION | Techmedica, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K900619 | CAAS UNICOMPARMENTAL KNEE SYSTEM | Techmedica, Inc. | 1990-06-11 | Traditional | PDF ↗ |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Concept, Inc. | 1990-06-05 | Traditional | PDF ↗ |
| K896856 | MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS | Osteonics Corp. | 1990-02-06 | Traditional | PDF ↗ |
| K894068 | KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM | Kirschner Medical Corp. | 1989-12-08 | Traditional | PDF ↗ |
| K881779 | WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM | Dow Corning Wright | 1988-08-31 | Traditional | PDF ↗ |
| K880155 | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE | Zimmer, Inc. | 1988-08-03 | Traditional | PDF ↗ |
| K873970 | KIRSCHNER UNICONDYLAR KNEE SYSTEM | Kirschner Medical Corp. | 1987-12-31 | Traditional | PDF ↗ |
Product code HSX · Class II · Orthopedic. Data: openFDA.