Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWQ — Predicate Candidate Screening
667 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
246 days90th percentile
667clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026-07-16 | 86 | 0 |
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 | 254 | 0 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026-05-06 | 33 | 0 |
| K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026-04-22 | 62 | 0 |
| K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | 2026-03-27 | 23 | 0 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 | 58 | 0 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 | 252 | 0 |
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 | 65 | 0 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026-02-12 | 139 | 0 |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025-12-22 | 126 | 0 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating | Alphatec Spine, Inc. | 2025-08-28 | 63 | 0 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 | 64 | 0 |
| K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025-05-23 | 98 | 0 |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 | 81 | 0 |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 | 50 | 0 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 | 26 | 1 |
| K243369 | Cervical Plating System | Life Spine, Inc. | 2024-12-11 | 42 | 0 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System | Stryker Spine | 2024-11-07 | 90 | 0 |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024-11-05 | 39 | 0 |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024-07-24 | 450 | 0 |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | 2024-05-24 | 84 | 0 |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | 2024-05-17 | 42 | 0 |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | 2024-05-17 | 21 | 0 |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | 2024-05-17 | 234 | 0 |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 | 57 | 0 |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024-04-16 | 263 | 0 |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | 2024-04-08 | 55 | 0 |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine | 2024-03-22 | 9 | 0 |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | 2024-03-18 | 24 | 0 |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | 2024-02-29 | 153 | 0 |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System | Alphatec Spine, Inc. | 2024-02-22 | 101 | 0 |
| K231715 | MONDRIAN™ Anterior Lumbar Plate System | Ctl Medical Corporation | 2024-01-26 | 227 | 0 |
| K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024-01-25 | 64 | 0 |
| K232318 | VICTORY™ Lumbar Plate System | Globus Medical, Inc. | 2023-10-31 | 89 | 0 |
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023-09-12 | 88 | 0 |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | 2023-08-02 | 62 | 0 |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar | L&K BIOMED Co., Ltd. | 2023-07-19 | 27 | 0 |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior | K&J Consulting Corp. | 2023-07-16 | 58 | 0 |
| K230993 | CODA™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | 2023-06-20 | 75 | 0 |
| K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2023-06-15 | 59 | 0 |
| K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. | 2023-06-13 | 53 | 0 |
| K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023-05-09 | 55 | 0 |
| K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia | Omnia Medical, LLC | 2023-04-12 | 54 | 0 |
| K223753 | Cervical Plate System | Double Medical Technology, Inc. | 2023-03-14 | 90 | 0 |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical, LLC | 2023-03-13 | 133 | 0 |
| K230301 | Athena III Cervical Plate System | Medyssey USA, Inc. | 2023-03-07 | 32 | 0 |
| K221053 | Magnes-C Anterior Cervical Plate System | Fellowship of Orthopaedic Researchers, Inc. | 2023-03-01 | 324 | 0 |
| K223627 | PreView-III™ Anterior Cervical Plate System | Nexus Spine, LLC | 2023-02-02 | 59 | 0 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate Sy | Aegis Spine, Inc. | 2023-01-11 | 30 | 0 |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | 2022-12-07 | 259 | 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