Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JWH — Predicate Candidate Screening
915 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
287 days90th percentile
915clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 | 88 | 0 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACT | Globus Medical, Inc. | 2026-07-31 | 30 | 0 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 | 58 | 0 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 | 55 | 0 |
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 | 28 | 0 |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 | 39 | 0 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 | 93 | 0 |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femo | Depuy Ireland UC | 2025-11-19 | 54 | 0 |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 | 29 | 0 |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 | 27 | 0 |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | 2025-09-25 | 28 | 0 |
| K251554 | Materialise TKA Guide System | Materialise NV | 2025-07-14 | 54 | 0 |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Inser | Encore Medical L.P. | 2025-07-08 | 28 | 0 |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Co | Encore Medical L.P. | 2025-07-02 | 71 | 0 |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 | 22 | 0 |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | 2025-05-08 | 267 | 0 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 | 23 | 0 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 | 27 | 0 |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025-03-24 | 88 | 0 |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025-03-13 | 30 | 0 |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Fe | Zimmer, Inc. | 2025-03-06 | 93 | 0 |
| K244039 | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2025-02-28 | 60 | 0 |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrume | Microport Orthopedics, Inc. | 2025-02-18 | 91 | 0 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Ins | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 | 56 | 0 |
| K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies | 2025-01-14 | 260 | 0 |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | 2025-01-13 | 87 | 0 |
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | 2024-12-20 | 84 | 0 |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Fe | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-12-04 | 76 | 0 |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | 2024-11-19 | 34 | 0 |
| K242984 | BKS Revision System | Ortho Development Corp. | 2024-10-25 | 29 | 0 |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Compo | Osteoremedies, LLC | 2024-10-02 | 54 | 0 |
| K241570 | Unity Total Knee System | Corin U.S.A. Limited | 2024-09-23 | 115 | 0 |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-09-12 | 30 | 0 |
| K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024-09-11 | 183 | 0 |
| K234044 | ACS® LD FB Knee System | Implantcast GmbH | 2024-09-06 | 260 | 0 |
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-08-01 | 20 | 0 |
| K241000 | ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System U | Depuy Ireland UC | 2024-07-11 | 90 | 0 |
| K240863 | Freedom® Total Knee System | Maxx Orthopedics, Inc. | 2024-07-02 | 96 | 0 |
| K240327 | UNIKO PointCloud™ Knee Instruments | Unik Orthopedics, Inc. | 2024-06-27 | 146 | 0 |
| K240875 | Unity Knee PS-C Tibial Insert | Corin U.S.A. Limited | 2024-06-26 | 89 | 0 |
| K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | Globus Medical, Inc. | 2024-06-20 | 101 | 0 |
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | 2024-04-26 | 84 | 0 |
| K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | 2024-04-19 | 458 | 0 |
| K232175 | XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co., Ltd. | 2024-04-14 | 268 | 0 |
| K234011 | AMF TT Cones | Lima Corporate S.P.A. | 2024-01-18 | 30 | 0 |
| K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | 2023-11-21 | 141 | 0 |
| K230078 | TRAX® CR Total Knee System | Amplitude | 2023-11-03 | 297 | 0 |
| K231947 | EVOLUTION® Cement Keel | Microport Orthopedics, Inc. | 2023-10-31 | 123 | 0 |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation | 2023-10-25 | 29 | 0 |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS- | Total Joint Othopedics, Inc. | 2023-09-08 | 29 | 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