510(k) Report

Devices descending from K031175

928 later devices reach Click'x Monoaxial Screws and Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+7K202771CD Horizon Spinal SystemMedtronic202021—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K173506LigaPASSMedicrea International SA20189—
+7K162824Z-Span Plate SystemZavation, LLC20172—
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K161627PASS LP Spinal SystemMedicrea International SA20167—
+7K151977icotec Pedicle SystemIcotec AG201630—
+7K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+7K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+7K131250Tiger Spine SystemCorelink, LLC201340—
+7K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K203023Pisces Spinal SystemOrtho Development Corporation20210—
+8K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+8K210306GII Spinal Fixation SystemColigne AG20210—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+8K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+8K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+8K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+8K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+8K133369Tiger Spine SystemCorelink, LLC201429—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—