510(k) Report

Devices descending from K974749

311 later devices reach Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+1K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+1K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K133103Aversion Pedicle Screw SystemK7, LLC20140—
+1K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+1K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+1K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+1K113173Nanovis Spinal SystemNanovis, LLC20122—
+1K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+1K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+1K100377Diamondback Spinal SystemEminent Spine201029—
+1K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+1K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+1K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+1K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc.2000176—
+1K983353SCS Spinal SystemOrthotec, Inc.19982—
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K203452Nano FortiFix® SystemNanovis, LLC20200—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K111301Instinct Java SystemZimmer Spine201131
+2K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+2K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+2K061342Malibu Spinal SystemSeaspine, Inc.2006801
+2K051942Malibu Spinal SystemSeaspine, Inc.20058111
+2K051663Malibu Spinal SystemSeaspine, Inc.200581—
+2K043232Ucr Spinal SystemSeaspine2004971
+2K032739Ucr Spinal SystemSeaspine2003174—
+2K021623Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc.2002175—
+2K9942885.0MM Spinal ScrewsOrtho Tec, LLC20000—
+2K993926Omniaxial ConnectorOrtho Tec, LLC19990—
+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—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K123552Instinct Java SystemZimmer Spine201301
+3K122592Instinct Java SystemZimmer Spine201301
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K120047Coral Spinal SystemTheken Spine, LLC201214—
+3K113270Instinct Java SystemZimmer Spine201121