510(k) Report

Devices descending from K113666

251 later devices reach Xia 3 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233684TriALTIS™ Spine SystemMedos International SARL20234—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K190751Connector SystemOrthofix, Inc.20193—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K242042TriALTIS™ Spine SystemMedos International SARL20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—