Orthopedic

PEK · Spinous Process Plate

Orthopedic · 21 CFR 888.3050 · Class 2

Overview

Product CodePEK
Device NameSpinous Process Plate
Regulation21 CFR 888.3050
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Classification Rationale

Class II.

Cleared Devices (48)

RecordDevice NameApplicantDecision DateDecision
K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCDec 1, 2025SESE
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCJan 18, 2024SESE
K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCNov 29, 2023SESE
K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineOct 19, 2023SESE
K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.Aug 15, 2023SESE
K223790Huvex Interspinous Fusion SystemDio Medical Corp.Mar 9, 2023SESE
K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLCAug 19, 2022SESE
K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc.Jul 8, 2022SESE
K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLCMar 11, 2022SESE
K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity, LLCDec 15, 2021SESE
K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLCDec 3, 2021SESE
K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLCDec 10, 2020SESE
K201704CoFix SystemParadigm Spine GmbHAug 4, 2020SESE
K182352SP-LINK™ SystemMedical Designs, LLCNov 21, 2018SESE
K180817AERIAL™ Interspinous FixationGlobus Medical, Inc.May 21, 2018SESE
K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.Mar 7, 2018SESE
K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics CorporationFeb 22, 2018SESE
K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLCMar 16, 2017SESE
K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd.Feb 16, 2017SESE
K163428HA Minuteman G3-R MIS Fusion PlateSpinal SimplicityFeb 2, 2017SESE
K161016Z-Clamp ISP SystemZavation, LLCOct 19, 2016SESE
K153302coflex-IFParadigm Spine, LLCSep 8, 2016SESE
K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.Jul 28, 2016SESE
K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.May 4, 2016SESE
K143631Benefix Interspinous Fixation SystemU&I CorporationSep 3, 2015SESE
K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCAug 20, 2015SESE
K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.Aug 7, 2015SESE
K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLCApr 2, 2015SESE
K143388Affix IIS Spinous Process Plate SystemNu Vasive, IncorporatedMar 5, 2015SESE
K140046SPINOUS PROCESS FUSION (SPF) PLATESpinal Simplicity, LLCJan 9, 2015SESE
K142378Interspinous Plate SystemPrecision Spine, Inc.Dec 18, 2014SESE
K141317ZIP MIS INTERSPINOUS FUSION SYSTEMAurora Spine, Inc.Nov 17, 2014SESE
K140236AILERON INTERSPINOUS FIXATION SYSTEMLife Spine, Inc.Oct 20, 2014SESE
K142213VIA SPINOUS PROCESS FIXATION SYSTEMSpineology, Inc.Sep 10, 2014SESE
K141508ROMEO 2 PAD POSTERIOR AXIAL DEVICESpineartAug 21, 2014SESE
K132765PFX SPINOUS PROCESS FIXATION SYSTEMInnovasis, Inc.Jul 14, 2014SESE
K140715ZIP MIS INTERSPINOUS FUSION SYSTEMAurora Spine, Inc.Apr 17, 2014SESE
K133363INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEMLdr Spine USA, Inc.Mar 7, 2014SESE
K133052AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.Dec 20, 2013SESE
K133091ZIP MIS INTERSPINOUS FUSION SYSTEMAurora SpineNov 27, 2013SESE
K132191SP-FIX SPINOUS PROCESS FIXATION PLATEGlobus Medical, Inc.Nov 22, 2013SESE
K132411AFFIX II SPINOUS PROCESS PLATE SYSTEMNu Vasive, IncorporatedNov 20, 2013SESE
K132968UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)Stryker SpineNov 18, 2013SESE
K130066SPECTRUM SPINE SPINOUS PROCESS DEVICESpectrum Spine IP Holdings, LLCNov 12, 2013SESE
K121924INTEGRA INTERSPINOUS PROCESS SYSTEMSeaspine, Inc.Sep 4, 2013SESE
K124014SUREFIX INTERSPINOUS FUSION SYSTEMJg Spine, LLCAug 9, 2013SESE
K131238AFFIX SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.Jul 2, 2013SESE
K130438AXLE INTERSPINOUS FUSION SYSTEMX-Spine Systems, Inc.Jun 27, 2013SESE

Top Applicants

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