510(k) Report

Devices descending from K092128

36 later devices reach Modification to: PSS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+1K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+1K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+1K141397Sure-Lok C Extended Tab Pedicle Screw SystemPrecision Spine, Inc.20140—
+1K131343Reform Pedicle Screw SystemSpinal USA201331—
+1K130279Reform Pedicle Screw SystemSpinal USA201331—
+1K122931S-Lok PSS SystemSpinal USA20120—
+1K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+2K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—