510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+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—
+8K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+8K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+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—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+9K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+9K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+9K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+9K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+10K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+10K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+10K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+10K203452Nano FortiFix® SystemNanovis, LLC20200—
+10K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+11K250769Dakota LP SystemPrecision Spine, Inc.20250—
+11K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K230329F3D Interbody SystemCorelink, LLC20230—
+12K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+12K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+13K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—