510(k) Report

Devices descending from K140123

22 later devices reach Polaris Spinal System -Translation Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+1K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—