Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MEH — Predicate Candidate Screening
159 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
359 days90th percentile
159clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025-11-05 | 268 | 0 |
| K251166 | Mfinity Femoral System | Medacta International S.A. | 2025-06-13 | 59 | 0 |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025-05-22 | 49 | 0 |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | 2025-05-01 | 269 | 0 |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025-03-10 | 87 | 0 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024-11-25 | 56 | 0 |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024-10-03 | 132 | 0 |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024-09-13 | 77 | 1 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024-08-01 | 50 | 0 |
| K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024-03-08 | 105 | 0 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy | Depuy Ireland UC | 2024-01-19 | 207 | 0 |
| K231178 | ACTERA™ hip system | Conformis, Inc. | 2023-05-23 | 27 | 0 |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023-01-13 | 325 | 0 |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal | Stryker | 2022-08-11 | 150 | 0 |
| K221104 | Actera™ hip system | Conformis, Inc. | 2022-08-04 | 112 | 1 |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022-01-07 | 214 | 0 |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | 2021-09-24 | 133 | 0 |
| K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021-08-16 | 74 | 0 |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021-05-20 | 83 | 0 |
| K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | 2020-10-16 | 282 | 0 |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020-09-21 | 131 | 0 |
| K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020-02-04 | 60 | 0 |
| K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019-03-25 | 265 | 0 |
| K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018-04-11 | 111 | 0 |
| K171273 | LINK® BiMobile(TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | 2018-01-19 | 263 | 0 |
| K171249 | Entrada™ hip stem | Ortho Development Corporation | 2017-08-24 | 118 | 0 |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017-05-01 | 257 | 0 |
| K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | 2017-04-26 | 209 | 1 |
| K153649 | Exactech® Novation® Element Press-fit Femoral Stem | Exactech, Inc. | 2016-08-31 | 254 | 0 |
| K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016-08-22 | 231 | 0 |
| K161155 | Origin Coxa Vara Hip Stem | Signature Orthopaedics Pty, Ltd. | 2016-07-19 | 85 | 0 |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy(Ireland) | 2016-07-19 | 109 | 0 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner | Signature Orthopaedics Pty, Ltd. | 2016-06-03 | 217 | 0 |
| K153772 | Corin TriFit TS Hip | Corin U.S.A. Limited | 2016-03-31 | 91 | 0 |
| K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015-10-21 | 204 | 0 |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015-09-25 | 177 | 1 |
| K122853 | NOVEL FIT AND FILL STEM | Howmedica Osteonics Corp. | 2013-02-01 | 136 | 0 |
| K112091 | H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, | Lima Corporate S.P.A. | 2012-11-09 | 477 | 0 |
| K121627 | SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM | Smith & Nephew, Inc. | 2012-10-15 | 133 | 0 |
| K113039 | SMITH & NEPHEW RADIOPAQUE TRIAL NECKS | Smith & Nephew, Inc. | 2012-10-05 | 359 | 0 |
| K121563 | CORIN TRIFIT TS HIP | Corin USA | 2012-10-05 | 129 | 0 |
| K113789 | MODULAR PROXIMALLY FLUTED HIP STEM | Smith & Nephew, Inc. | 2012-04-19 | 119 | 0 |
| K113320 | NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIG | Exactech, Inc. | 2012-03-16 | 127 | 0 |
| K113107 | MSA HIP SYSTEM | Global Manufacturing Technology | 2011-12-15 | 56 | 0 |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | Howmedica Osteonics Corp. | 2011-09-28 | 26 | 1 |
| K103479 | NOVEL TAPERED HIP STEM | Stryker Corp. | 2011-03-10 | 104 | 0 |
| K103497 | CERAMIC FEMORAL HEAD | United Orthopedic Corp. | 2011-03-04 | 95 | 0 |
| K102172 | MSA HIP SYSTEM | Global Manufacturing Technology | 2011-03-01 | 211 | 0 |
| K102424 | PREVISION HIP SYSTEM WITH RECON RING | Aesculap Implant Systems, LLC | 2010-12-09 | 106 | 0 |
| K093472 | TRINITY ACETABULAR SYSTEM | Corin USA | 2010-11-23 | 382 | 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