510(k) Report

Devices descending from K040442

551 later devices reach Protex Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+8K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+8K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K193219G Surgical Marksman SystemG Surgical, LLC20191—
+8K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+8K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+9K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K203452Nano FortiFix® SystemNanovis, LLC20200—
+9K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K230329F3D Interbody SystemCorelink, LLC20230—
+11K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—