Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWP — Predicate Candidate Screening
430 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
288 days90th percentile
430clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015-07-29 | 257 | 0 |
| K150753 | OASYS System | Stryker Corporation | 2015-06-09 | 78 | 0 |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015-06-04 | 65 | 0 |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015-04-29 | 210 | 0 |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 | 84 | 2 |
| K142253 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-23 | 252 | 0 |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 | 64 | 0 |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 | 146 | 0 |
| K142741 | OASYS System | Stryker Corporation | 2015-01-15 | 113 | 0 |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m | 2014-12-22 | 102 | 0 |
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | Ebi, LLC | 2014-12-15 | 266 | 0 |
| K142460 | EXPEDIUM Spine System/Synapse System | Johnson and Johnson | 2014-10-01 | 29 | 1 |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Synthes USA Products, LLC | 2014-09-25 | 73 | 0 |
| K141284 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2014-07-23 | 68 | 0 |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | 2014-07-01 | 249 | 0 |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-06-02 | 195 | 0 |
| K140645 | GIBRALT ROD-TO-ROD CROSS CONNECTORS | Exactech Sarasota | 2014-04-11 | 29 | 0 |
| K133374 | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014-03-19 | 138 | 0 |
| K133214 | BLACKBIRD SPINAL SYSTEM | Choicespine, LP | 2014-03-07 | 140 | 0 |
| K131833 | CENTURION POCT SYSTEM | Orthofix, Inc. | 2014-01-30 | 224 | 0 |
| K132122 | KESTREL POSTERIOR CERVICAL SPINE SYSTEM | Omni Surgical, LLC Dba Spine360 | 2014-01-22 | 196 | 0 |
| K133698 | SYNAPSE SYSTEM | Synthes USA Products, LLC | 2014-01-16 | 44 | 0 |
| K133094 | CERTEX OCT SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2013-12-11 | 72 | 0 |
| K132504 | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Corelink, LLC | 2013-11-25 | 105 | 0 |
| K132900 | MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Intelligent Implant Systems, LLC | 2013-10-25 | 39 | 0 |
| K131427 | LOTUS | Spinal Elements, Inc. | 2013-10-24 | 160 | 0 |
| K132332 | MOUNTAINEER OCT SPINAL SYSTEM | Medos International SARL | 2013-08-22 | 27 | 0 |
| K131156 | LANX SPINAL FIXATION SYSTEM | Lanx, Inc. | 2013-05-24 | 30 | 0 |
| K123906 | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION | Medtronic Sofamor Danek USA, Inc. | 2013-04-01 | 103 | 0 |
| K121979 | PASS OCT SPINAL SYSTEM | Medicrea International | 2013-03-21 | 258 | 0 |
| K123783 | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL I | Globus Medical, Inc. | 2013-03-14 | 94 | 0 |
| K123656 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION S | Medtronic Sofamor Danek USA, Inc. | 2013-02-25 | 89 | 0 |
| K121877 | GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL | Exactech, Inc. | 2013-02-12 | 229 | 0 |
| K123232 | SPINEOLOGY SPINOUS PROCESS PLATE | Spineology, Inc. | 2013-02-07 | 114 | 0 |
| K123093 | STABILINK MIS SPINAL FIXATION SYSTEM | Southern Spine, LLC | 2012-12-20 | 79 | 0 |
| K123568 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2012-12-18 | 28 | 0 |
| K122509 | VERTIFLEX SPINOUS PROCESS FIXATION PLATE | Vertiflex, Inc. | 2012-12-17 | 122 | 0 |
| K121725 | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | Pioneer Surgical Technology, Inc. | 2012-11-07 | 148 | 0 |
| K122292 | RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM | Reliance Medical Systems, LLC | 2012-10-24 | 85 | 0 |
| K120998 | SOLSTICE CROSS CONNECTOR | Life Spine | 2012-10-01 | 182 | 0 |
| K122378 | NEXTGEN ALTIUS OCT SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-09-20 | 45 | 1 |
| K121136 | RENOIR POSTERIOR CERVIAL FIXATION SYSTEM | Accel Spine | 2012-08-09 | 118 | 0 |
| K121808 | CASIAN, 3.5/4.5 CONNECTORS | K2m, Inc. | 2012-07-20 | 30 | 0 |
| K121115 | M.U.S.T PEDICLE SCREW SYSTEM | Medacta International | 2012-07-18 | 97 | 1 |
| K121191 | VERTEX RCCONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-06-29 | 71 | 0 |
| K113593 | NEXTGEN ALTIUS OCT SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-04-17 | 134 | 0 |
| K113324 | REXIOUS HOOK FIXATION SYSTEMS | Dio Medical Co., Ltd. | 2012-03-28 | 139 | 0 |
| K112757 | PIONEER POSTERIOR CERVICO THORACIC SYSTEM | Pioneer Surgical Technology, Inc. | 2012-03-12 | 172 | 1 |
| K113346 | NEON SYSTEM | Ulrich GmbH & Co. KG | 2012-02-28 | 106 | 0 |
| K112595 | COFLEX-F | Paradigm Spine, LLC | 2012-02-13 | 159 | 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