510(k) Report

Devices descending from K111358

151 later devices reach Synthes Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+1K120838Synthes Matrix SystemSynthes Spine201216—
+1K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+1K120928Synthes Matrix SystemSynthes Spine20120—
+1K120571Synthes Uss ConnectorSynthes Spine201274—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+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—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—