Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MQP — Predicate Candidate Screening
279 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
228 days90th percentile
279clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026-07-31 | 60 | 0 |
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | 2026-07-10 | 102 | 0 |
| K253158 | VyBrate™ VBR System | Vy Spine, LLC | 2026-01-07 | 103 | 0 |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024-11-07 | 167 | 0 |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024-04-04 | 206 | 0 |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024-03-08 | 161 | 0 |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | 2024-02-13 | 298 | 0 |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023-10-06 | 77 | 0 |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy | Arftx Medical, LLC | 2022-10-06 | 472 | 0 |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020-12-23 | 103 | 0 |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020-05-29 | 120 | 0 |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini | Nu Vasive, Incorporated | 2020-02-26 | 70 | 0 |
| K192117 | Small VBR™ | Ulrich GmbH & Co. KG | 2019-11-01 | 87 | 0 |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | 2019-10-24 | 252 | 0 |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | 2019-10-11 | 57 | 0 |
| K183054 | SYNMESH System | Depuy Synthes Spine | 2019-05-23 | 202 | 0 |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | 2019-05-08 | 99 | 0 |
| K183197 | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 | 136 | 0 |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2019-02-22 | 63 | 0 |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019-01-16 | 29 | 0 |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage Syst | K2m, LLC | 2018-11-28 | 259 | 0 |
| K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | 2018-11-16 | 121 | 0 |
| K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018-09-19 | 264 | 0 |
| K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018-09-19 | 124 | 0 |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage Syste | Medos International SARL | 2018-06-11 | 179 | 0 |
| K173800 | Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy | Camber Spine Technologies | 2018-02-02 | 50 | 0 |
| K172330 | Blustone Synergy Silica System | Blustone Synergy | 2017-12-21 | 141 | 0 |
| K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017-12-20 | 82 | 0 |
| K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017-11-09 | 448 | 0 |
| K172323 | Omnia Medical VBR | Omnia Medical, LLC | 2017-10-26 | 86 | 0 |
| K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) Syste | Choicespine | 2017-09-15 | 100 | 0 |
| K171704 | CAPRI Corpectomy Cage System | K2m | 2017-08-31 | 84 | 0 |
| K162133 | VerteFIT Corpectomy Cage System | Ldr Spine USA, Inc. | 2017-05-16 | 288 | 0 |
| K170055 | CAPRI Corpectomy Cage System | K2m | 2017-04-13 | 97 | 0 |
| K170271 | NuVasive(r) Monolith Corpectomy System | Nu Vasive, Incorporated | 2017-03-30 | 62 | 0 |
| K152460 | Rectangular Corpectomy Cage | Amendia, Inc. | 2015-12-22 | 116 | 0 |
| K151538 | NuVasive PEEK Corpectomy Railed System | Nu Vasive, Incorporated | 2015-09-04 | 88 | 0 |
| K151167 | NuVasive PEEK Corpectomy System | Nu Vasive, Incorporated | 2015-09-03 | 125 | 0 |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | Oxford Performance Materials | 2015-07-10 | 352 | 0 |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | Nuvasive, Inc. | 2015-02-20 | 193 | 0 |
| K142996 | StaXx(R) XD System | Spine Wave, Inc. | 2015-02-19 | 126 | 0 |
| K143490 | VERTA Corpectomy Cage | Camber Spine | 2015-01-26 | 49 | 0 |
| K142030 | STGC-LORDOTIC | Cardinal Spine, LLC | 2015-01-23 | 182 | 0 |
| K142016 | CAPRI | K2m, Inc. | 2014-11-06 | 104 | 0 |
| K142150 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2014-10-29 | 85 | 0 |
| K140563 | LATERAL VBR SYSTEM | Nu Vasive, Incorporated | 2014-08-07 | 155 | 0 |
| K133802 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2014-04-17 | 125 | 0 |
| K123758 | TASMIN R | Signus Medizintechnik GmbH | 2014-01-14 | 403 | 0 |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Pioneer Surgical Technology, Inc. | 2013-12-24 | 195 | 0 |
| K133207 | STAXX(R) SYSTEM | Spine Wave, Inc. | 2013-12-06 | 49 | 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