510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+8K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+8K202771CD Horizon Spinal SystemMedtronic202021—
+8K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+8K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K173506LigaPASSMedicrea International SA20189—
+8K162824Z-Span Plate SystemZavation, LLC20172—
+8K160640PASS XS Spinal SystemMedicrea International SA20160—
+8K161627PASS LP Spinal SystemMedicrea International SA20167—
+8K153413PASS LP Spinal SystemMedicrea International SA20160—
+8K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+9K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+9K210306GII Spinal Fixation SystemColigne AG20210—
+9K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+10K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+10K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+10K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+10K180324Patriot Spinal Fixation SystemValorus Spine20180—