Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNH — Predicate Candidate Screening
309 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
247 days90th percentile
309clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 | 129 | 0 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 | 29 | 0 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 | 53 | 0 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 | 149 | 0 |
| K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016-08-30 | 26 | 0 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 | 350 | 0 |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 | 149 | 0 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 | 57 | 0 |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 | 417 | 0 |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 | 79 | 0 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 | 60 | 0 |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 | 83 | 0 |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 | 177 | 0 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 | 89 | 0 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 | 79 | 0 |
| K142957 | Ideal pedicle screw spinal system | Jiangsu Ideal Medical Science & Technology Co., Ltd. | 2015-01-30 | 108 | 0 |
| K142655 | CB PROT II Posterior Spinal System | Chin Bone Technique Corp | 2015-01-26 | 130 | 0 |
| K140359 | MAXIMIS SPINAL FIXATION SYSTEM | Valorem Surgical | 2015-01-07 | 329 | 0 |
| K142290 | KangLi pedical screw spinal system | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-11-24 | 98 | 0 |
| K134011 | GENERAL SPINAL SYSTEM | Changzhou Dean Medical Instrument Co, Ltd. | 2014-09-03 | 247 | 0 |
| K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, | Spinevision S.A. | 2014-06-30 | 222 | 0 |
| K140053 | KANGLI PEDICLE SCREW SPINAL SYSTEM | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-06-26 | 168 | 0 |
| K141376 | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FI | Nexxt Spine, LLC | 2014-06-26 | 30 | 0 |
| K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | Kalitec Direct, LLC | 2014-06-19 | 93 | 0 |
| K140787 | PLS (POSTERIOR LUMBAR SYSTEM) | Sintea Plustek, LLC | 2014-05-30 | 60 | 0 |
| K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2014-05-20 | 36 | 0 |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2014-05-14 | 209 | 0 |
| K133690 | TRUE SPINAL FUSSION SYSTEM | Innovative Surgical Designs | 2014-05-07 | 156 | 0 |
| K133287 | PRESSON SPINAL FIXATION SYSTEM | Nexus Spine, LLC | 2014-02-25 | 123 | 0 |
| K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | Spine Wave, Inc. | 2014-01-10 | 162 | 0 |
| K132218 | PERFIX ILIAC SCREW SYSTEM | U&I Corporation | 2013-12-17 | 153 | 0 |
| K132101 | ANAX 5.5 SPINAL SYSTEM | U&I Corporation | 2013-11-25 | 140 | 0 |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | Osseus Fusion Systems, LLC | 2013-08-08 | 50 | 0 |
| K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | Captiva Spine | 2013-08-08 | 71 | 0 |
| K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2013-05-31 | 116 | 0 |
| K122994 | INTRAMEDULLARY NAIL SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2013-04-12 | 197 | 0 |
| K123487 | GSO GS1 CANNULATED SCREW SYSTEM | Gold Standard Orthopaedics, LLC | 2013-03-11 | 118 | 0 |
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2013-02-15 | 129 | 6 |
| K123476 | MEGA 5.5 SPINE SYSTEM | Lsk Biopartners, Inc. | 2013-01-08 | 56 | 0 |
| K122592 | INSTINCT JAVA SYSTEM | Zimmer Spine | 2013-01-04 | 133 | 0 |
| K122814 | GALLEON PEDICLE SCREW SYSTEM | Everest Spine, LLC | 2012-12-03 | 81 | 0 |
| K120832 | FORTEX PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2012-10-23 | 218 | 3 |
| K121016 | RANGE SPINAL SYSTEM (MESA AND DENALI) | K2m, Inc. | 2012-06-27 | 84 | 0 |
| K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | Ldr Spine USA, Inc. | 2012-06-27 | 106 | 0 |
| K111940 | S 100 PEDICLE SCREW SYSTEM | Renovis Surgical Technologies, LLC | 2012-05-15 | 312 | 0 |
| K120353 | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYST | Bm Korea Co., Ltd. | 2012-05-09 | 93 | 0 |
| K120491 | DSS STABILIZATION SYSTEM-RIGID | Paradigm Spine, LLC | 2012-05-09 | 82 | 0 |
| K103573 | ARTS2 SPINAL FIXATION SYSTEM | Advanced Medical Technologies | 2011-12-28 | 387 | 0 |
| K110633 | LANCER PEDICLE SCREW SYSTEM | Spinal Solutions, LLC | 2011-12-15 | 286 | 8 |
| K111995 | XINGTM SPINE SYSTEM | Implanova Co., Ltd. | 2011-12-12 | 152 | 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