510(k) Report

Devices descending from K022623

294 later devices reach 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+1K193219G Surgical Marksman SystemG Surgical, LLC20191—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+1K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+1K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+1K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+1K133103Aversion Pedicle Screw SystemK7, LLC20140—
+1K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+1K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+1K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+1K123717UcentumUlrich GmbH & Co. KG2013171
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+1K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+1K113173Nanovis Spinal SystemNanovis, LLC20122—
+1K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+1K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+1K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+1K100377Diamondback Spinal SystemEminent Spine201029—
+1K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+1K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+2K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K203452Nano FortiFix® SystemNanovis, LLC20200—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K111301Instinct Java SystemZimmer Spine201131
+2K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123552Instinct Java SystemZimmer Spine201301
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122592Instinct Java SystemZimmer Spine201301
+3K113270Instinct Java SystemZimmer Spine201121
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—