Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MRW · Predicate Candidate Screening
78 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
267 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261209 | Ion-L | SurGenTec, LLC | 2026-06-11 | 59 | 0 |
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PC | Providence Medical Technology, Inc. | 2026-05-14 | 174 | 0 |
| K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | 2026-03-19 | 169 | 0 |
| K251714 | Ion-C | SurGenTec, LLC | 2026-01-16 | 227 | 0 |
| K250679 | FFX Facet Fixation System | Sc Medica | 2025-12-04 | 273 | 0 |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-11-20 | 55 | 0 |
| K252153 | FFX Facet Fixation System | Sc Medica | 2025-10-16 | 99 | 0 |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-07-10 | 20 | 0 |
| K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025-05-22 | 56 | 0 |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025-05-21 | 268 | 0 |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine | 2025-03-24 | 97 | 0 |
| K243265 | Ion 3D | SurGenTec, LLC | 2024-12-04 | 50 | 0 |
| K242650 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-09-20 | 16 | 0 |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024-06-25 | 70 | 0 |
| K241416 | Ion 3D | SurGenTec, LLC | 2024-06-17 | 31 | 0 |
| K232468 | SC Medica FFX | Sc Medica | 2024-05-09 | 268 | 0 |
| K240085 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-04-18 | 98 | 0 |
| K240086 | Ion 3D | SurGenTec, LLC | 2024-02-08 | 28 | 0 |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023-12-19 | 267 | 0 |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation Syste | K&J Consulting Corporation | 2023-12-13 | 89 | 0 |
| K230297 | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | 2023-08-11 | 190 | 0 |
| K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022-12-09 | 252 | 0 |
| K222515 | FaSet Fixation System | Dio Medical Corporation | 2022-10-05 | 47 | 0 |
| K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022-02-25 | 254 | 0 |
| K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019-12-16 | 77 | 0 |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation S | Medos International SARL | 2019-11-20 | 90 | 0 |
| K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019-10-11 | 294 | 0 |
| K180729 | FaSet Fixation System | Huvexel Co. , Ltd. | 2018-06-28 | 100 | 0 |
| K173198 | Facet Screw Fixation System | U&I Corporation | 2018-01-03 | 93 | 0 |
| K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017-02-16 | 77 | 0 |
| K161798 | FacetBRIDGE® System | Ldr Spine USA, Inc. | 2016-08-04 | 35 | 0 |
| K152137 | FacetBRIDGE System | Ldr Spine USA | 2016-01-25 | 178 | 0 |
| K150223 | Facet-Link Stabilization Platform | Facet-Link, Inc. | 2015-04-28 | 88 | 0 |
| K142980 | Proficient (TM) Facet Screw Spine System | Spine Wave, Inc. | 2015-01-16 | 93 | 0 |
| K132859 | INTEGRA FACET FIXATION SYSTEM | Seaspine, Inc. | 2013-11-18 | 67 | 0 |
| K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | Spectrum Spine, LLC | 2013-10-28 | 110 | 0 |
| K130863 | FACET SCREW SYSTEM | Spinal USA | 2013-08-09 | 134 | 0 |
| K131417 | FACET FIXX | Nexxt Spine, LLC | 2013-07-12 | 57 | 0 |
| K120597 | KOMPREDA | Custom Spine, Inc. | 2013-05-03 | 430 | 0 |
| K123932 | ZYGAFIX SPINAL FACET SCREW SYSTEM | X-Spine Systems, Inc. | 2013-05-01 | 132 | 0 |
| K123497 | FACET SCREW SYSTEM | Facet-Link, Inc. | 2013-02-28 | 107 | 0 |
| K123218 | ILLICO FS FACET FIXATION SYSTEM | Alphatec Spine, Inc. | 2012-11-28 | 44 | 0 |
| K121551 | RESOLUTE FACET SCREW SYSTEM | Neurostructures, LLC | 2012-10-23 | 151 | 0 |
| K120340 | VENUS FACET SCREW SYSTEM | Apollo Spine, Inc. | 2012-10-19 | 259 | 0 |
| K121850 | Typhoon(TM) Facet Screw Fixation System | Choicespine, LP | 2012-09-20 | 87 | 0 |
| K113011 | SPARTAN S3 FACET SYSTEM | Amendia, Inc. | 2011-12-06 | 56 | 0 |
| K110170 | RAPTOR FACET FIXATION SYSTEM | Alphatec Spine, Inc. | 2011-11-28 | 312 | 0 |
| K112097 | GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 | Exactech, Inc. | 2011-11-21 | 122 | 0 |
| K101762 | VIPER F2 FACET FIXATION SYSTEM | Depuy Spine, Inc. | 2010-11-15 | 146 | 0 |
| K101765 | KYPHON ANCHOR FACET SCREW SYSTEM | Medtronic Spine, LLC | 2010-10-22 | 121 | 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