Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDI — Predicate Candidate Screening
564 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
261 days90th percentile
564clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 | 273 | 0 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddb | Signature Orthopaedics Pty, Ltd. | 2026-03-12 | 188 | 0 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Line | Zimmer Biomet | 2025-07-31 | 255 | 0 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Aceta | Smith & Nephew, Inc. | 2024-10-21 | 214 | 0 |
| K241716 | Global Modular Replacement System, Modular Replacement Syste | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 | 49 | 0 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 | 59 | 0 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 | 70 | 0 |
| K222056 | Global Modular Replacement System, Modular Replacement Syste | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 | 198 | 1 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 | 177 | 0 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 | 69 | 0 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 | 29 | 0 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 | 263 | 0 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 | 162 | 3 |
| K203588 | ELEOS™ Limb Salvage System | Onkos Surgical | 2021-02-05 | 59 | 3 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 | 59 | 0 |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | 2020-12-10 | 185 | 0 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020-08-13 | 247 | 1 |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | 2020-07-16 | 412 | 0 |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020-07-09 | 101 | 1 |
| K191735 | CPT Hip System | Zimmer, Inc. | 2020-03-20 | 266 | 0 |
| K191056 | Conformity stem, cemented | United Orthopedic Corporation | 2020-01-03 | 259 | 0 |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | 2019-08-28 | 92 | 0 |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2019-02-11 | 266 | 0 |
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018-09-28 | 168 | 0 |
| K162125 | MALUC™ Total Hip Arthroplasty System | Surgtech, Inc. | 2017-05-10 | 282 | 0 |
| K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | 2016-11-17 | 227 | 0 |
| K153057 | FitRite™ Total Hip Arthroplasty System | Excera Orthopedics, Inc. | 2016-06-23 | 246 | 0 |
| K153725 | Corin TaperFit Hip Stem | Corin U.S.A. Limited | 2016-03-25 | 88 | 0 |
| K153216 | Alpine Cemented Hip System | Ortho Development Corporation | 2016-02-18 | 105 | 0 |
| K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015-10-14 | 30 | 0 |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral | Biomet Manufacturing, LLC | 2015-06-25 | 269 | 0 |
| K142761 | Corin TaperFit Hip Stem | Corin USA | 2015-04-03 | 190 | 0 |
| K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) | Biomet, Inc. | 2014-10-27 | 159 | 0 |
| K142295 | Sirius Femoral Stem, Size 30A | Biomet, Inc. | 2014-09-15 | 28 | 0 |
| K141370 | RENOVIS CEMENTED HIP SYSTEM | Renovis Surgical Technologies, Inc. | 2014-09-02 | 98 | 0 |
| K130610 | SIRIUS FEMORAL STEM | Biomet, Inc. | 2013-08-30 | 176 | 2 |
| K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | 2013-06-28 | 219 | 0 |
| K123501 | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS | Biomet, Inc. | 2013-02-27 | 106 | 0 |
| K121056 | METS MODULAR PROXIMAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-20 | 167 | 0 |
| K121055 | METS MODULAR TOTAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-19 | 166 | 0 |
| K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | Materialise NV | 2012-06-15 | 351 | 0 |
| K120578 | ACCOLADE II HIP STEM | Howmedica Osteonics | 2012-03-29 | 31 | 1 |
| K111848 | EXETER X3 RIMFIT ACETABULAR CUP | Stryker Corp. | 2011-10-05 | 98 | 0 |
| K110290 | EXETER HIP STEM | Howmedica Osteonics Corp. | 2011-09-27 | 238 | 1 |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009-12-17 | 22 | 0 |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009-06-12 | 65 | 0 |
| K090208 | BIOPRO FEMORAL HEADS | Biopro, Inc. | 2009-05-22 | 114 | 3 |
| K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL | Medacta International S.A. | 2008-12-29 | 97 | 1 |
| K082239 | DEPUY C-STEM AMT | DePuy Orthopaedics, Inc. | 2008-08-29 | 22 | 0 |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | 2008-06-02 | 96 | 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