Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JEY — Predicate Candidate Screening
293 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
285 days90th percentile
293clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026-07-25 | 302 | 0 |
| K252246 | Leforte MMF System | Jeil Medical Corporation | 2026-04-02 | 258 | 0 |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | 2025-12-19 | 80 | 0 |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS | Inion OY | 2025-11-07 | 182 | 0 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024-08-16 | 98 | 0 |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024-07-12 | 127 | 0 |
| K233874 | tmCMF Solution | Techmah Cmf | 2024-07-11 | 217 | 0 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implan | Meticuly Co., Ltd. | 2024-04-30 | 225 | 0 |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | 2024-01-13 | 159 | 0 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | 2023-09-26 | 222 | 0 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-05 | 142 | 0 |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD M | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 | 99 | 0 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | 2022-11-10 | 275 | 0 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 | 135 | 0 |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022-07-18 | 494 | 0 |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022-02-04 | 63 | 0 |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2021-08-05 | 309 | 0 |
| K202918 | OsteoSync™ Ti Dental Mesh | Sites Medical, LLC | 2021-07-14 | 288 | 0 |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | 2021-05-19 | 194 | 0 |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | 2021-02-12 | 443 | 0 |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (2 | Synthes (USA) Products, LLC | 2020-09-10 | 59 | 0 |
| K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020-07-29 | 670 | 0 |
| K192747 | Yxoss CBR® | Reoss GmbH | 2020-06-17 | 261 | 0 |
| K191997 | FAICO CMF System | Faico Medical, LLC | 2020-04-22 | 271 | 0 |
| K193143 | Stryker Facial iD Plating System | Stryker | 2020-03-26 | 134 | 0 |
| K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2020-03-26 | 134 | 0 |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-12-30 | 96 | 0 |
| K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | 2019-12-05 | 433 | 0 |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019-11-22 | 218 | 0 |
| K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | 2019-06-28 | 102 | 0 |
| K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019-03-29 | 189 | 0 |
| K182305 | Stryker Facial iD Plating System | Stryker | 2019-01-07 | 136 | 0 |
| K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | 2018-12-28 | 338 | 0 |
| K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2018-10-11 | 255 | 0 |
| K180962 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2018-08-13 | 123 | 0 |
| K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018-07-10 | 285 | 0 |
| K170697 | GBR system | Surgident | 2018-05-24 | 443 | 0 |
| K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018-03-26 | 235 | 0 |
| K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018-02-23 | 126 | 0 |
| K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017-11-21 | 336 | 0 |
| K170773 | Stryker Universal Mesh | Stryker | 2017-11-08 | 239 | 0 |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | Stryker | 2017-10-31 | 64 | 0 |
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017-08-08 | 190 | 0 |
| K171364 | MP LeFort I Plates | Stryker | 2017-07-24 | 76 | 0 |
| K160363 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | 2016-10-20 | 254 | 0 |
| K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015-12-10 | 114 | 0 |
| K150965 | LeForte System II | Jeil Medical Corporation | 2015-09-17 | 160 | 0 |
| K143730 | GBR System | Jeil Medical Corporation | 2015-06-10 | 163 | 0 |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker | 2015-05-05 | 235 | 0 |
| K143338 | Argulated Locking Plates | Osteomed LP | 2015-04-01 | 132 | 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