510(k) Report

Devices descending from K141804

21 later devices reach Polaris Spinal System - HA Coated through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+1K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+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—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+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—