510(k) Report

Devices descending from K082358

428 later devices reach Smith & Nephew, Inc. Patient Matched Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251709MedCAD® AccuStride™ SystemMedcad20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K233300POWEReam 1/4 DriveStryker Instruments20231—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K223421MedCAD AccuPlan Orthopedics SystemMedcad20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K241470CORE Shoulder SystemLinkBio Corp.202501
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—