FDA Product Code
FDA Product Code MBH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3565
510(k) Clearances — 146 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | 2026-09-17 | Traditional | PDF ↗ |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026-09-08 | Traditional | PDF ↗ |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026-08-21 | Traditional | PDF ↗ |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 | Traditional | PDF ↗ |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 | Traditional | PDF ↗ |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 | Traditional | PDF ↗ |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 | Traditional | PDF ↗ |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 | Traditional | PDF ↗ |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 | Traditional | PDF ↗ |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 | Traditional | PDF ↗ |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 | Traditional | PDF ↗ |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | United Orthopedic Corporation | 2025-07-31 | Traditional | PDF ↗ |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 | Traditional | PDF ↗ |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 | Traditional | PDF ↗ |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 | Traditional | PDF ↗ |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 | Traditional | PDF ↗ |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 | Special | PDF ↗ |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | 2024-11-22 | Traditional | PDF ↗ |
| K242412 | Agility Symmetric Total Knee System | Medisurge, LLC | 2024-11-06 | Traditional | PDF ↗ |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | 2024-10-29 | Special | PDF ↗ |
| K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | 2024-10-03 | Traditional | PDF ↗ |
| K240938 | The Optimotion Blue Plus Knee System | Optimotion Implants, LLC | 2024-06-27 | Traditional | PDF ↗ |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | 2024-06-18 | Traditional | PDF ↗ |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. | 2024-04-26 | Traditional | PDF ↗ |
| K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | 2023-12-11 | Traditional | PDF ↗ |
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | Conformis, Inc. | 2023-09-08 | Special | PDF ↗ |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | Conformis, Inc. | 2023-07-21 | Traditional | PDF ↗ |
| K230295 | ATTUNE® Revision Cones | Depuy Ireland UC | 2023-03-10 | Traditional | PDF ↗ |
| K221705 | U2 Total Knee System-PF+ | United Orthopedic Corporation | 2023-02-28 | Traditional | PDF ↗ |
| K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023-01-20 | Traditional | PDF ↗ |
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | 2022-10-17 | Traditional | PDF ↗ |
| K222566 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2022-10-17 | Traditional | PDF ↗ |
| K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022-08-23 | Traditional | PDF ↗ |
| K220049 | Optimotion Implants Porous Metal-Backed Patella | Optimotion Implants, LLC | 2022-03-14 | Traditional | PDF ↗ |
| K212941 | Porous Patella | Encore Medical, L.P. Dba Djo Surgical | 2022-01-20 | Traditional | PDF ↗ |
| K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP | Depuy Ireland UC | 2022-01-18 | Special | PDF ↗ |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022-01-05 | Special | PDF ↗ |
| K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021-10-01 | Traditional | PDF ↗ |
| K203779 | Symmetric Total Knee System | Signal Medical Corporation | 2021-06-10 | Traditional | PDF ↗ |
| K211246 | LEGION CR Porous Plus HA Femoral Components | Smith & Nephew, Inc. | 2021-05-24 | Special | PDF ↗ |
| K210554 | Physica system | Lima Corporate S.P.A. | 2021-04-06 | Traditional | PDF ↗ |
| K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | Encore Medical L.P. | 2021-03-30 | Traditional | PDF ↗ |
| K210566 | LEGION Porous CR Narrow Femoral Components | Smith & Nephew, Inc. | 2021-03-25 | Special | PDF ↗ |
| K201084 | Physica system | Lima Corporate S.P.A. | 2020-12-14 | Traditional | PDF ↗ |
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | 2020-11-25 | Traditional | PDF ↗ |
| K193312 | UNIKO PointCloud Knee Instruments | Unik Orthopedics, Inc. | 2020-08-12 | Traditional | PDF ↗ |
| K201364 | LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG | 2020-07-17 | Traditional | PDF ↗ |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | Howmedica Osteonics Corp. | 2020-05-13 | Traditional | PDF ↗ |
| K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | 2020-04-07 | Traditional | PDF ↗ |
| K200113 | LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG | 2020-03-18 | Traditional | PDF ↗ |
| K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | 2019-08-15 | Traditional | PDF ↗ |
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018-11-26 | Traditional | PDF ↗ |
| K181794 | Truliant Porous Femoral Components | Exactech, Inc. | 2018-09-28 | Special | PDF ↗ |
| K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018-05-17 | Traditional | PDF ↗ |
| K180317 | EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System | Microport Orthopedics, Inc. | 2018-05-04 | Traditional | PDF ↗ |
| K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018-02-02 | Traditional | PDF ↗ |
| K173417 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018-01-30 | Traditional | PDF ↗ |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017-11-16 | Traditional | PDF ↗ |
| K171365 | Arthrex Knee Systems | Arthrex, Inc. | 2017-11-07 | Traditional | PDF ↗ |
| K171991 | EMPOWR Porous Knee System | Encore Medical L.P. | 2017-10-04 | Traditional | PDF ↗ |
| K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell | Microport Orthopedics, Inc. | 2017-06-15 | Traditional | PDF ↗ |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | Total Joint Orthopedics, Inc. | 2016-10-27 | Traditional | PDF ↗ |
| K153657 | Vanguard XP Knee System | Biomet, Inc. | 2016-05-10 | Traditional | PDF ↗ |
| K153776 | Optetrak One Logic Femoral Components | Exactech, Inc. | 2016-03-10 | Special | PDF ↗ |
| K153586 | Arthrex iBalance TKA System | Arthrex, Inc. | 2016-02-19 | Traditional | PDF ↗ |
| K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base | Microport Orthopedics, Inc. | 2015-11-16 | Traditional | PDF ↗ |
| K152252 | Arthrex iBalance TKA System | Arthrex, Inc. | 2015-11-16 | Traditional | PDF ↗ |
| K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes | United Orthopedic Corporation | 2015-09-25 | Traditional | PDF ↗ |
| K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics, Inc. | 2015-06-26 | Traditional | PDF ↗ |
| K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015-05-20 | Traditional | PDF ↗ |
| K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | Depuy(Ireland) | 2015-02-13 | Traditional | PDF ↗ |
| K143366 | ADVANCE Porous Coated Spiked Tibial Base | Microport Orthopedics, Inc. | 2015-01-21 | Special | PDF ↗ |
| K143393 | Triathlon Tritanium Cone Augments | Stryker Orthopaedics | 2015-01-13 | Traditional | PDF ↗ |
| K141407 | VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL | Biomet, Inc. | 2014-10-27 | Traditional | PDF ↗ |
| K141635 | ARTHREX IBALANCE TKA SYSTEM | Arthrex, Inc. | 2014-09-03 | Traditional | PDF ↗ |
| K141840 | TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH | Zimmer, Inc. | 2014-09-03 | Traditional | PDF ↗ |
| K140735 | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS | Microport Orthopedics, Inc. | 2014-08-29 | Traditional | PDF ↗ |
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | Stryker Orthopaedics | 2014-08-05 | Traditional | PDF ↗ |
| K140302 | OPTETRAK LOGIC POROUS FEMORAL COMPONENTS | Exactech, Inc. | 2014-07-30 | Traditional | PDF ↗ |
| K140883 | VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT | Biomet, Inc. | 2014-07-30 | Traditional | PDF ↗ |
| K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | United Orthopedic Corp. | 2014-06-13 | Traditional | PDF ↗ |
| K140257 | SIGNATURE PLANNER, SIGNATURE GUIDES | Materialise NV | 2014-04-02 | Traditional | PDF ↗ |
| K132873 | VANGUARD XP KNEE SYSTEM | Biomet, Inc. | 2013-12-11 | Traditional | PDF ↗ |
| K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | Stryker Orthopaedics | 2013-11-26 | Traditional | PDF ↗ |
| K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE | Stryker | 2013-05-03 | Traditional | PDF ↗ |
| K122218 | ADVANCE TOTAL KNEE SYSTEM-PATELLA | Wrightmedicaltechnologyinc | 2013-03-21 | Special | PDF ↗ |
| K122160 | VANGUARD XP KNEE SYSTEM | Biomet Manufacturing Corp | 2013-03-20 | Traditional | PDF ↗ |
| K123459 | ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM | Zimmer, Inc. | 2013-02-22 | Traditional | PDF ↗ |
| K122745 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | Zimmer, Inc. | 2012-12-05 | Traditional | PDF ↗ |
| K121771 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | Zimmer, Inc. | 2012-11-07 | Traditional | PDF ↗ |
| K122053 | SHAPEMATCH CUTTING GUIDE | Stryker Corp. | 2012-10-24 | Traditional | PDF ↗ |
| K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | 2012-08-07 | Traditional | PDF ↗ |
| K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL | Zimmer Trabecular Metal Technology | 2012-06-29 | Traditional | PDF ↗ |
| K103598 | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | Wrightmedicaltechnologyinc | 2011-10-17 | Traditional | PDF ↗ |
| K110950 | CONSENSUS KNEE SYSTEM | Consensus Orthopedics, Inc. | 2011-06-27 | Traditional | PDF ↗ |
| K110533 | STRYKER PATIENT SPECIFIC CUTTING GUIDE | Stryker Corp. | 2011-05-19 | Traditional | PDF ↗ |
| K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | Zimmer Trabecular Metal Technology, Inc. | 2011-02-15 | Traditional | PDF ↗ |
| K102927 | CONSENSUS KNEE SYSTEM | Consensus Orthopedics, Inc. | 2011-01-26 | Traditional | PDF ↗ |
| K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | Zimmer Trabecular Metal Technology | 2010-12-13 | Traditional | PDF ↗ |
Product code MBH · Class II · Orthopedic. Data: openFDA.