Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MNI — Predicate Candidate Screening
303 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
224 days90th percentile
303clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 | 143 | 0 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 | 201 | 0 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 | 448 | 0 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 | 230 | 0 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Ped | Spinevision S.A. | 2016-04-04 | 75 | 0 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 | 56 | 0 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 | 53 | 0 |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 | 168 | 0 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 | 396 | 0 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 | 246 | 0 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 | 56 | 1 |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 | 104 | 0 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 | 51 | 0 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 | 48 | 0 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 | 27 | 0 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 | 29 | 0 |
| K150294 | DPZ Pedicular Fixation System | Osteomed Implantes, Ltda | 2015-06-05 | 119 | 0 |
| K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | 2015-04-08 | 27 | 0 |
| K150049 | PASS LP Spinal System | Medicrea International | 2015-02-10 | 29 | 0 |
| K141253 | NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM | New Era Orthopaedics, LLC | 2015-01-09 | 240 | 0 |
| K140738 | PASS LP SPINAL SYSTEM | Medicrea International | 2014-11-04 | 224 | 0 |
| K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTO | Spineart | 2014-09-10 | 65 | 0 |
| K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM | Precision Spine, Inc. | 2014-06-26 | 29 | 0 |
| K132788 | MYSPINE PEDICLE SCREW PLACEMENT GUIDES | Medacta International | 2014-05-23 | 259 | 0 |
| K140229 | GENERAL SPINAL SYSTEM | Tianjin Walkman Biomaterial Co., Ltd. | 2014-04-29 | 89 | 0 |
| K133103 | AVERSION PEDICLE SCREW SYSTEM | K7, LLC | 2014-01-27 | 119 | 0 |
| K130073 | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2013-12-16 | 339 | 0 |
| K132757 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2013-11-20 | 77 | 0 |
| K132280 | ALTUS SPINE PEDICLE SCREW SYSTEM | Altus Partners | 2013-10-31 | 100 | 0 |
| K130958 | TRUE SPINAL FIXATION SYSTEM | Innovative Surgical Designs | 2013-10-17 | 195 | 0 |
| K132412 | INERTIA MIS PEDICLE SCREW SYSTEM | Nexxt Spine, LLC | 2013-10-10 | 69 | 0 |
| K132361 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2013-10-03 | 65 | 0 |
| K132644 | LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD | Corentec Co., Ltd. | 2013-09-19 | 24 | 0 |
| K132365 | SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION | Accel Spine | 2013-08-20 | 21 | 2 |
| K131522 | CORE PEDICLE SCREW SYSTEM | Core-Nexus | 2013-08-09 | 73 | 0 |
| K132154 | CAPSURE PS SYSTEM | Spine Wave, Inc. | 2013-08-09 | 28 | 0 |
| K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATIO | Spinevision S.A. | 2013-07-30 | 173 | 0 |
| K131343 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2013-07-24 | 76 | 0 |
| K130279 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2013-06-20 | 135 | 0 |
| K123521 | RELIANCE SPINAL SCREW SYSTEM | Reliance Medical Systems, LLC | 2013-02-07 | 84 | 0 |
| K122931 | S-LOK PSS SYSTEM | Spinal USA | 2012-11-20 | 57 | 0 |
| K122163 | CERTEX SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2012-10-31 | 103 | 0 |
| K122332 | TOWERLOX PEDICLE SCREW SYSTEM | Captiva Spine | 2012-10-16 | 75 | 0 |
| K122233 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2012-10-11 | 77 | 0 |
| K121615 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2012-08-15 | 75 | 0 |
| K121172 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2012-08-08 | 113 | 0 |
| K120646 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2012-06-07 | 97 | 0 |
| K120899 | RANGE SPINAL SYSTEM, UNIT ROD | K2m, Inc. | 2012-05-25 | 60 | 0 |
| K120879 | LEXUS CERVICAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2012-05-23 | 61 | 0 |
| K120099 | RANGE SPINAL SYSTEM (MESA AND DENALI) | K2m, Inc. | 2012-05-18 | 127 | 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