Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LPH — Predicate Candidate Screening
563 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
322 days90th percentile
563clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 | 230 | 0 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 | 56 | 0 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems w | Nextstep Arthopedix, LLC | 2026-06-05 | 613 | 0 |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | 2026-05-19 | 390 | 0 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | 2026-02-04 | 169 | 0 |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026-01-28 | 300 | 0 |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 | 157 | 0 |
| K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 | 73 | 0 |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025-11-12 | 149 | 0 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 | 86 | 0 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 | 116 | 0 |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025-06-06 | 211 | 0 |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025-06-05 | 267 | 0 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 | 267 | 0 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025-04-10 | 272 | 0 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 | 59 | 0 |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025-01-22 | 30 | 0 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 | 270 | 0 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024-11-08 | 155 | 0 |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024-10-11 | 22 | 0 |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | 2024-10-07 | 83 | 0 |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024-10-07 | 59 | 0 |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024-04-18 | 101 | 0 |
| K231522 | EMPHASYS™ Dual Mobility System | Depuy Ireland UC | 2024-02-15 | 265 | 0 |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-12-21 | 51 | 0 |
| K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023-10-27 | 56 | 0 |
| K230011 | Mpact Extension | Medacta International S.A. | 2023-09-20 | 260 | 0 |
| K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlan | Depuy Ireland UC | 2023-09-20 | 28 | 0 |
| K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2023-05-09 | 270 | 0 |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023-04-14 | 275 | 0 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023-02-27 | 133 | 0 |
| K223779 | EMPOWR™ blade stem | Encore Medical, LLC | 2023-02-13 | 59 | 0 |
| K223348 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical, Inc. | 2023-01-30 | 89 | 0 |
| K211047 | CoCr Head | Zimmer GmbH | 2023-01-10 | 642 | 0 |
| K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022-11-04 | 148 | 0 |
| K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022-10-03 | 298 | 0 |
| K220336 | Mg-PSZ Ceramic Femoral Head | Theken Companies | 2022-09-30 | 235 | 0 |
| K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | 2022-09-06 | 92 | 0 |
| K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022-08-18 | 139 | 0 |
| K212815 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical | 2022-07-06 | 306 | 0 |
| K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022-07-01 | 437 | 1 |
| K201348 | DePuy 3D Additive TriFlange Acetabular Cup | Depuy International, Ltd. | 2022-06-16 | 756 | 0 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022-05-24 | 449 | 0 |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022-05-18 | 90 | 0 |
| K212761 | Biocore9 Acetabular Cup System | Biocore9, LLC | 2022-05-17 | 259 | 0 |
| K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-03-09 | 27 | 0 |
| K212187 | Restoration® Modular Hip System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-03-01 | 231 | 0 |
| K211330 | R3 Large Head Liners | Smith & Nephew, Inc. | 2022-01-19 | 261 | 0 |
| K202568 | Mpact® 3D Metal Implants - DMLS Technology | Medacta International S.A. | 2021-12-20 | 472 | 0 |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LI | Microport Orthopedics, Inc. | 2021-10-01 | 638 | 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