510(k) Report

Devices descending from K062853

53 later devices reach Modification to Stryker Spine Oasys System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111719Oasys Spinal SystemStryker Spine201239—
+1K101183Modification to: Oasys SystemStryker Spine20100—
+1K093670Modification to: Oasys SystemStryker Spine201041Class I
+1K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+1K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+1K072568Modification to Oasys SystemStryker Spine200744—
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+2K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+2K142741OASYS SystemStryker Corporation201537—
+2K113346Neon SystemUlrich GmbH & Co. KG20121—
+2K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+3K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+3K230614Cortium™Ulrich Medical USA20230—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K150753OASYS SystemStryker Corporation201534—
+3K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K151755OASYS (r) SystemStryker Corporation201533—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+5K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+5K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+8K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+8K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—