Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MBH — Predicate Candidate Screening
143 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
247 days90th percentile
143clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 | 346 | 0 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma | Zimmer, Inc. | 2026-03-09 | 164 | 0 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 | 149 | 0 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabili | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 | 91 | 0 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 | 85 | 0 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 | 84 | 0 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 | 59 | 0 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Compo | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 | 116 | 0 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Pat | United Orthopedic Corporation | 2025-07-31 | 247 | 0 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 | 52 | 0 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replace | Restor3D, Inc. | 2025-03-27 | 111 | 0 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 | 255 | 0 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 | 63 | 0 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 | 26 | 0 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS | Zimmer, Inc. | 2024-11-22 | 88 | 0 |
| K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | 2024-11-06 | 84 | 0 |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | 2024-10-29 | 18 | 0 |
| K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | 2024-10-03 | 238 | 0 |
| K240938 | The Optimotion™ Blue Plus Knee System | Optimotion Implants, LLC | 2024-06-27 | 83 | 0 |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Pa | Depuy Ireland UC | 2024-06-18 | 99 | 0 |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg | Zimmer, Inc. | 2024-04-26 | 85 | 0 |
| K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. | 2024-01-18 | 79 | 0 |
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Pa | Depuy Ireland UC | 2023-12-11 | 132 | 1 |
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replace | Conformis, Inc. | 2023-09-08 | 28 | 0 |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Ident | Conformis, Inc. | 2023-07-21 | 266 | 0 |
| K230295 | ATTUNE® Revision Cones | Depuy Ireland UC | 2023-03-10 | 36 | 0 |
| K221705 | U2 Total Knee System-PF+ | United Orthopedic Corporation | 2023-02-28 | 260 | 0 |
| K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023-01-20 | 56 | 0 |
| K222566 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2022-10-17 | 54 | 0 |
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | 2022-10-17 | 413 | 0 |
| K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022-08-23 | 57 | 0 |
| K220049 | Optimotion Implants Porous Metal-Backed Patella | Optimotion Implants, LLC | 2022-03-14 | 67 | 0 |
| K212941 | Porous Patella | Encore Medical, L.P. Dba Djo Surgical | 2022-01-20 | 127 | 1 |
| K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP | Depuy Ireland UC | 2022-01-18 | 46 | 1 |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022-01-05 | 29 | 0 |
| K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021-10-01 | 161 | 0 |
| K203779 | Symmetric Total Knee System | Signal Medical Corporation | 2021-06-10 | 164 | 0 |
| K211246 | LEGION CR Porous Plus HA Femoral Components | Smith & Nephew, Inc. | 2021-05-24 | 28 | 0 |
| K210554 | Physica system | Lima Corporate S.P.A. | 2021-04-06 | 40 | 0 |
| K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | Encore Medical L.P. | 2021-03-30 | 55 | 0 |
| K210566 | LEGION Porous CR Narrow Femoral Components | Smith & Nephew, Inc. | 2021-03-25 | 27 | 0 |
| K201084 | Physica system | Lima Corporate S.P.A. | 2020-12-14 | 235 | 0 |
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Pa | Depuy Ireland UC | 2020-11-25 | 112 | 1 |
| K193312 | UNIKO PointCloud™ Knee Instruments | Unik Orthopedics, Inc. | 2020-08-12 | 257 | 0 |
| K201364 | LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG | 2020-07-17 | 56 | 0 |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded wi | Howmedica Osteonics Corp. | 2020-05-13 | 48 | 0 |
| K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | 2020-04-07 | 349 | 0 |
| K200113 | LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG | 2020-03-18 | 61 | 0 |
| K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | 2019-08-15 | 122 | 0 |
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018-11-26 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda