510(k) Report

Devices descending from K161114

42 later devices reach HIGH V+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+1K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+2K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+2K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+2K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+2K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—