Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PEK — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
306 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | 2025-12-01 | 63 | 0 |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion | Spinal Simplicity, LLC | 2024-01-18 | 28 | 0 |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusio | Spinal Simplicity, LLC | 2023-11-29 | 28 | 0 |
| K232484 | KeyLift™ Expandable Interlaminar Stabilization System | Amplio Spine, LLC | 2023-10-19 | 64 | 0 |
| K231807 | primaLOK™ SP Interspinous Fusion System | Wenzel Spine, Inc. | 2023-08-15 | 56 | 0 |
| K223790 | Huvex Interspinous Fusion System | Dio Medical Corp. | 2023-03-09 | 80 | 0 |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman | Spinal Simplicity, LLC | 2022-08-19 | 135 | 0 |
| K221399 | ZIP™ MIS Interspinous Fusion System | Aurora Spine, Inc. | 2022-07-08 | 56 | 0 |
| K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | 2022-03-11 | 263 | 0 |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman | Spinal Simplicity, LLC | 2021-12-15 | 105 | 0 |
| K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021-12-03 | 64 | 0 |
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020-12-10 | 332 | 0 |
| K201704 | CoFix System | Paradigm Spine GmbH | 2020-08-04 | 43 | 0 |
| K182352 | SP-LINK™ System | Medical Designs, LLC | 2018-11-21 | 84 | 0 |
| K180817 | AERIAL™ Interspinous Fixation | Globus Medical, Inc. | 2018-05-21 | 53 | 0 |
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplast | Globus Medical, Inc. | 2018-03-07 | 47 | 0 |
| K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | 2018-02-22 | 122 | 0 |
| K163471 | Kalitec Direct InSePtion™ MIS Fixation System | Kalitec Direct, LLC | 2017-03-16 | 94 | 0 |
| K162849 | Huvex Interspinous Fixation System | Dio Medical Co., Ltd. | 2017-02-16 | 128 | 0 |
| K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017-02-02 | 58 | 0 |
| K161016 | Z-Clamp ISP System | Zavation, LLC | 2016-10-19 | 191 | 0 |
| K153302 | coflex-IF | Paradigm Spine, LLC | 2016-09-08 | 300 | 0 |
| K160465 | Spinal Elements' Spinous Process Plate System | Spinal Elements, Inc. | 2016-07-28 | 160 | 0 |
| K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2016-05-04 | 65 | 0 |
| K143631 | Benefix Interspinous Fixation System | U&I Corporation | 2015-09-03 | 255 | 0 |
| K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015-08-20 | 55 | 0 |
| K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2015-08-07 | 30 | 0 |
| K142217 | Reliance Interspinous Plate System | Reliance Medical Systems, LLC | 2015-04-02 | 233 | 0 |
| K143388 | Affix IIS Spinous Process Plate System | Nu Vasive, Incorporated | 2015-03-05 | 99 | 0 |
| K140046 | SPINOUS PROCESS FUSION (SPF) PLATE | Spinal Simplicity, LLC | 2015-01-09 | 366 | 0 |
| K142378 | Interspinous Plate System | Precision Spine, Inc. | 2014-12-18 | 114 | 0 |
| K141317 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Aurora Spine, Inc. | 2014-11-17 | 181 | 0 |
| K140236 | AILERON INTERSPINOUS FIXATION SYSTEM | Life Spine, Inc. | 2014-10-20 | 263 | 0 |
| K142213 | VIA SPINOUS PROCESS FIXATION SYSTEM | Spineology, Inc. | 2014-09-10 | 29 | 0 |
| K141508 | ROMEO 2 PAD POSTERIOR AXIAL DEVICE | Spineart | 2014-08-21 | 76 | 0 |
| K132765 | PFX SPINOUS PROCESS FIXATION SYSTEM | Innovasis, Inc. | 2014-07-14 | 313 | 0 |
| K140715 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Aurora Spine, Inc. | 2014-04-17 | 27 | 0 |
| K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | Ldr Spine USA, Inc. | 2014-03-07 | 126 | 0 |
| K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2013-12-20 | 84 | 0 |
| K133091 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Aurora Spine | 2013-11-27 | 58 | 0 |
| K132191 | SP-FIX SPINOUS PROCESS FIXATION PLATE | Globus Medical, Inc. | 2013-11-22 | 130 | 0 |
| K132411 | AFFIX II SPINOUS PROCESS PLATE SYSTEM | Nu Vasive, Incorporated | 2013-11-20 | 110 | 0 |
| K132968 | UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) | Stryker Spine | 2013-11-18 | 56 | 0 |
| K130066 | SPECTRUM SPINE SPINOUS PROCESS DEVICE | Spectrum Spine IP Holdings, LLC | 2013-11-12 | 306 | 0 |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Seaspine, Inc. | 2013-09-04 | 429 | 0 |
| K124014 | SUREFIX INTERSPINOUS FUSION SYSTEM | Jg Spine, LLC | 2013-08-09 | 225 | 0 |
| K131238 | AFFIX SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2013-07-02 | 62 | 0 |
| K130438 | AXLE INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2013-06-27 | 126 | 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