510(k) Report

Devices descending from K992147

451 later devices reach Triple-Fix Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+9K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K202771CD Horizon Spinal SystemMedtronic202021—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+9K180376K2M Patient Specific RodsK2m, Inc.20182—
+9K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+9K160640PASS XS Spinal SystemMedicrea International SA20160—
+9K161627PASS LP Spinal SystemMedicrea International SA20167—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+10K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+10K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+10K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+10K210306GII Spinal Fixation SystemColigne AG20210—
+10K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+11K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+11K253545Vulcan Spinal SystemK2m, Inc.20260—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—